Infection and death following use of heater/cooler systems during heart surgery: Mycobacterium chimaera

Written by Clinical Negligence on February 7, 2017

Concerns have been raised across the medical profession regarding the development of an invasive, yet slowly developing, infection in patients following cardiothoracic surgery.

The cause of the development of the infection, called Mycobacterium chimaera (M. Chimaera), has been traced back to a Sorin 3T heater-cooler machine which is commonly used during cardiothoracic procedures such as coronary bypass or valve replacement operations.

The Sorin 3T heater-cooler machine is manufactured by the Sorin Group which is now part of the LivaNova Group. In America, the machine is known as the Stockert 3T system.

Heater-cooler systems are commonly used during cardiac surgeries, as well as other medical and surgical procedures, to warm or cool a patient with the aim to optimize patient care and improve patient outcomes. Devices such as the Sorin 3T heater-cooler unit utilise water tanks which provide temperature-controlled water to warming or cooling blankets covering the patient during surgery.

According to the Food and Drug Administration (FDA), the federal agency of the United States Department of Health and Human Services and Public Health England, there is the potential for the Sorin 3T heater-cooler system to carry Mycobacterium chimaera (M. Chimaera) bacteria in its water tanks and transmit infection to the patient during the procedure through the air and via the device’s exhaust vent.

A recent study demonstrates a link between the Mycobacterium chimaera (M. Chimaera) which has infected European patients undergoing open-chest cardiac surgery and the Sorin 3T heater-cooler system. This has been supported by the Sorin Group’s own testing during which it found contamination in the water supply and production line at its heater-cooler manufacturing facility in Germany.

Between 2010 and 2015 the FDA was informed of 32 cases of the infection – 8 cases in the US and 24 cases in Europe – linked to this particular device. Examination of past medical records is leading to this number steadily increasing. Recently, inquests have been held or arranged into the death of patients who have suffered from this complication. Coroners have recorded that deaths have been caused by the Mycobacterium chimaera (M.Chimaera) infection following heart surgery.

The difficulty which faces doctors in diagnosing and treating patients who have developed a Mycobacterium chimaera (M. Chimera) infection is that the bacterium is very slow growing and it may take several months or years for patients to develop any symptoms. The infection proves fatal to approximately half of affected patients but until recently, Mycobacterium chimaera (M. Chimaera) has not been routinely tested for.

Symptoms of Mycobacterium chimaera (M. Chimaera) are:

  • Fever lasting more than one week
  • Loss of energy
  • Night sweats
  • Joint or muscle pain
  • Redness, heat or pus around a surgical incision
  • In infants, a failure to grow or gain weight
  • Difficulty breathing
  • Persistent cough or cough with blood
  • Nausea
  • Vomiting

Since September 2014, all newly manufactured Sorin 3T Systems have been subjected to a cleaning and disinfection procedure as part of the manufacturing process and the contamination is believed to have been eliminated from the Sorin 3T heater-cooler production line.

In 2015 Public Health England published advice to providers of cardiothoracic surgery warning that a high percentage of UK devices may be contaminated. Sorin has issued a Field Safety Notice advising that all machines be tested.

Public Health England also suspects that the infection risk may be applicable to other similar machines.

Hospitals which have provided treatment to patients using a Sorin 3T System have been directed to inform the operating surgeons and doctors of the possibility that patients may have been subjected to an Mycobacterium chimaera infection and to determine a method for patient follow-up and monitoring. Patients who become unwell after valve replacement surgery should be tested for Mycobacterium chimaera infection. There is, however, considerable concern at the delay in information about the risk of  Mycobacterium chimaera (M. Chimaera) being publicised to doctors and patients.

Mail on Sunday Online has reported that the NHS is now tracing the 47,000 people who have had cardiac surgery since 2013. Read More: Click Here

Freeths LLP is currently advising relatives of patients who have been infected by Mycobacterium chimaera from the Sorin 3T heater-cooler system.

Should anyone have any queries regarding a potential claim relating to a Mycobacterium chimaera infection following heart surgery, please contact our clinical negligence team for further information.

Paul Balen

Paul Balen
Consultant
0845 050 3289
paul.balen@freeths.co.uk

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Serious issues at Manchester hospitals

Written by Clinical Negligence on January 25, 2017

Patients at hospitals run by Pennine Acute Hospital NHS Trust faced years of negligent treatment, misdiagnoses, poor clinical judgement, apathetic and unqualified staff, short-staffing, and chronic under resourcing.

This was the verdict of a report commissioned in early 2016 by the Trust itself and prepared by its Director of Maternity Care. Unfortunately for patients at North Manchester General and Royal Oldham Hospitals the report was then buried and only came to light (after repeated denials from the Trust that it even existed) following an investigation by the Manchester Evening News. Once exposed the report made national headlines.

The failings highlighted in the report make for disturbing and in many cases tragic reading. Among the more appalling examples of negligence identified at the Trust between 2010 and June 2016 (when the report was completed) include:

  • A premature baby being left to die alone in a room used to dispose of medical waste
  • Another baby who died because of an elementary failure to check its mother’s blood type
  • Routine failures to take basic observations and keep basic records
  • Lab results left unchecked
  • Patient records incorrectly, incompletely, or only tardily filled out
  • Lack of effective performance monitoring of the Trust’s historically high numbers of agency/locum staff
  • Newborn babies’ heart rates not being monitored properly, leading to serious and lifelong health problems (including brain damage) which would otherwise have been preventable
  • A woman misdiagnosed as mentally ill when she was actually suffering from a cerebral haemorrhage, and who was subsequently allowed to die of hypoxia over the course of several days
  • A woman who was left with a permanent colostomy because her treatable faecal peritonitis was missed by surgeons on three separate occasions over the course of 24 hours

The report identified several root causes of the problems, including an overarching “embedded culture of not responding to the needs of vulnerable women.” Habitual short-staffing was another issue with an especially negative impact on maternity care:

The effect of poor staffing numbers in clinics has meant women have fragmented care, suffered long waits and not had appropriate management.

The report goes on to describe long-standing “poor decision-making” by maternity staff resulting in “significant harm to women and real issues relating to the management of women in labour” which in turn led to “high levels of harm for babies in particular.” Over reliance on locums (one third of total staff) likewise translated into low levels of doctors and nurses with appropriate skills and experience.

The report found that between 2010 and 2015 the Trust paid out over £50million in compensation claims, more than any other NHS Trust in England. Half of this amount was maternity-related. In 2012 the Clinical Negligence Schemes Trust (a division of the NHSLA) was so alarmed by the level  of compensation payouts it warned the Trust to clean up its act. In 2014 meanwhile the Trust was subject to an external investigation because of the unusually high level of maternity deaths. The report makes it clear that very little changed. By June 2016 there had been no fewer than 12 “serious” maternity incidents since April 2016 alone, including the death of a mother, the death of two babies, and three still-births.

Following exposure of the report all families involved in serious incidents have been invited to meet with the Trust’s head of midwifery. Maternity services are now being overseen by another Trust (Central Manchester NHS Foundation Trust) and a new management team has been put in place on secondment from Salford Royal Hospital Trust. No more high-risk pregnancies are being sent to Manchester General. Trust bosses say that they are now working full-time on improving services and recruiting more and better-qualified staff. It is to be expected that many more compensation claims will follow however.

Freeths LLP provides a comprehensive clinical negligence service with free initial advice. If anyone has any queries flowing from these events please contact Phil McGough at our Nottingham office for further information.

Phillip McGough

Clinical Negligence Executive

+44(0)845 050 3290

phillip.mcgough@freeths.co.uk

Crisis in maternity care

Written by Clinical Negligence on January 17, 2017

A recent study undertaken jointly by the National Childbirth Trust and the National Federation of Women’s Institutes (NFWI) has found that 50% of new mothers have experienced “red flag” events during labour. Examples of red flag events include: waiting more than 30 minutes to be given pain relief, waiting more than 1 hour to receive stitches following an episiotomy and women in labour being left without a midwife.

The findings of the report highlight that there is a chronic shortage of midwives and this is undermining the delivery of high quality care for women and their families. In the report mothers described their care as “robotic” and that they felt it was “humiliating and degrading” and that they were treated as “a product on a conveyor belt”.

Louise Silverton, Director for midwifery at the Royal College of Midwives states “The fact that half of women have experienced a red flag event is hugely worrying. It is a sign of services under too much pressure, with too few resources and not enough staff. This ongoing shortage of midwives and underfunding of services is not delivering the service that women and their families need, and it is storing up health problems for the future that could be prevented.”

The report is published only a day after Kent Coroner, Roger Hatch, ruled that “failures, inadequate diagnosis and treatment” by the maternity unit at Maidstone and Tunbridge Wells NHS Trust led to the death of  Frances Cappuccini after she gave birth to her son (http://www.bbc.co.uk/news/uk-england-kent-38634044 ).

A spokesman for the Department of Health has recently been quoted as saying: “We want the NHS to be one of the safest places in the world to have a baby. There are over 1,500 more midwives on our maternity units since 2010, and more than 6,300 currently in training, with our changes to student funding creating thousands more training places by the end of this parliament.”

Going through labour can be a very traumatic experience for any women and negative experiences of childbirth can increase the risks for maternal postpartum depression and negatively affect a mother’s attitude toward future pregnancies and choice of delivery method. We can only hope that with further training and investment of funds, the services provided by our maternity units will improve.

If you, or anyone you know, has concerns about the quality of care received during childbirth, please contact a member of our clinical negligence team for a free, confidential discussion on the details below.

Laura Bland H&S smallCarolyn Lowe small

Humanitarian Crisis in NHS East Midlands Hospitals

Written by Clinical Negligence on January 10, 2017

The Red Cross has declared that the NHS is suffering a humanitarian crisis following it assisting various UK hospitals to free up beds and place patients back into the community. Chief executive Mike Adamson said:

The British Red Cross is on the front line, responding to the humanitarian crisis in our hospital and ambulance services across the country…we’ve seen people sent home without clothes; some suffer falls and are not found for days, while others are not washed because there is no carer there to help them.

The British Red Cross provided support to staff at the East Midlands Ambulance Service across Nottingham, Leicester, Lincoln, Kettering and Northampton on 1 January. There have been more than 18,000 trolley waits of four or more hours in the last week.

Dr Mark Holland, president of the Royal College of Acute Medicine has stated that “we have been predicting that we would face a winter from hell. I think that time has arrived.”

Dr Taj Hassan, president of the Royal College of Emergency Medicine stated that “the emergency care system is on its knees, despite the huge efforts of staff who are struggling to cope with the intense demands being put upon them.” He also added that “the scale of the crisis affecting emergency care systems has reached new heights, as we predicted…we entered this winter in the worst state of affairs possible.”

Professor Keith Willett, medical director for acute care at NHS England also admitted that demand is at its highest level ever with staff being placed under “a level of pressure we haven’t seen before”. It has been reported that 50 of 152 English trusts were at the highest or second highest levels of pressure over the Christmas period. During the period, seven trusts had to declare the highest level of emergency 15 times, meaning they were unable to give patients comprehensive care.

These comments also come after three people died at Worcestershire Royal Hospital A&E after waiting for treatment in a hospital corridor. One person died from cardiac arrest after waiting 35 hours, a second had an aneurysm and died despite treatment and it is also alleged that a patient was found hanged on a ward. Other patients had been waiting up to 54 hours for treatment. The hospital confirmed the delays and pressures on clinical treatment stating:

We can confirm that both of our A&E departments experienced an extremely busy Christmas and New Year period, and these pressures are continuing.

Peter Pinfield, chairman of Healthwatch Worcestershire – the patient care watchdog for the county – has called for an investigation saying the public needed to know the reasons behind the delays.

Here at Freeths, we specialise in clinical negligence claims, and have successfully settled claims ranging from emergency department failures, post-partum and inter-partum failures to misdiagnoses of illnesses, along with many others. If you or anyone you know has been affected by an incident of suspected medical negligence, please contact us on the details below.

Jane Williams H&S small

Jane Williams

Partner

+44(0)845 272 5724

jane.williams@freeths.co.uk

K REYNOLDS

Karen Reynolds

Partner

+44(0)845 272 5677

karen.reynolds@freeths.co.uk

Siobhan Genever H&S small

Siobhan Genever

Director

+44(0)845 272 5677

siobhan.genever@freeths.co.uk

 

NHSLA LAUNCHES MEDIATION SCHEME AFTER SUCCESSFUL PILOT

Written by Clinical Negligence on December 8, 2016

The NHSLA has announced that following a successful pilot scheme it has launched its new mediation service.  The scheme is intended to provide injured claimants with a possible resolution of their claim without the need to litigate the claim through the courts.

Contracts have been awarded to a panel of mediators.  Claimant solicitors have long thought that mediation is an ideal way of resolving disputes in Clinical Negligence claims.  Mediation has the potential to save costs and avoid protracted heavily disputed and expensive litigation.  For a long time, our lawyers at Freeths LLP have routinely offered mediation or arbitration as a way of resolving a dispute but in the past have faced firm resistance from Defendants.  We therefore fully endorse and welcome this NHS approved scheme.

Helen Vernon of the NHSLA says about the scheme:

“Mediation is an excellent forum for dispute resolution and provides injured patients and their families with an opportunity for face to face explanations and apologies when things go wrong and reducing the need for unnecessary litigation.”

Our lawyers are often told by clients that one of the most important things they hope to gain by bringing an action is an explanation and answers to their questions about what went wrong with their treatment.  Clients often also seek an apology where appropriate, which is often not achieved via formal litigation.  If mediation can provide these things as well as compensation then it is something to be very enthusiastic about.

However it remains essential that a Claimant in a Clinical Negligence action has access to skilled, specialist lawyers to analyse evidence and secure fair compensation.  It is important to realise that mediation should be used at an appropriate time in a case and this is usually after expert medical evidence has been gathered to assess the injury and the appropriate level damages that should be sought.

At Freeths LLP we have specialist and extremely experienced lawyers who can assist an injured Claimant in compiling evidence to value a claim and to assist with the mediation process.  Our consultant Paul Balen is also a mediator with Trust Mediation, one of the firms appointed to the NHSLA’s panel of mediators.

If you are concerned about medical treatment that you or a family member or friend has received or would like to discuss your options about seeking redress via mediation then please get in touch with us via the details below.

Carolle White
Chartered Legal Executive
+44(0)115 985 3367
carolle.white@freeths.co.uk…

UK ambulances fail to get to life-or-death calls on time

Written by Clinical Negligence on November 30, 2016

It has emerged that UK ambulances are struggling to reach the seriously ill and injured fast enough due to rising demand which has left NHS emergency trusts at breaking point.

Only one of the UK’s 13 ambulance trusts is meeting its target of reaching people with life-threatening conditions within 8 minutes. Delays waiting for A&E staff to be free to perform a patient handover amounted to 503,499 hours in 2015-2016 in England, Wales and Northern Ireland – a rise of 52% in two years.

It has also been revealed that it is not uncommon for trusts to run out of ambulances to send at peak times. NHS ambulance trusts took 9.4m calls in 2015.

In the East Midlands, patients waited 1 minute and 42 seconds longer for an ambulance to arrive than in 2013-2014. The College of Paramedics chair Andrew Newton said the situation was of ‘great concern’.

 If you, or anyone you know has been affected by a delay in an ambulance reaching you or a delay in being transferred to a hospital for emergency care, please contact us via the details below.

 

Naomi Solomon
Solicitor
+44(0)845 274 6830
naomi.solomon@freeths.co.uk

Claire Cooper
Solicitor
+44(0)845 274 6830
claire.cooper@freeths.co.uk

 

 

 …

Obstetric and Midwifery failures in Manchester

Written by Clinical Negligence on November 24, 2016

Today there is widespread reporting of the extremely sad case of a premature baby whom was left to die alone in a sluice room rather than in their mother’s arms. This serious incident (and many others) has been revealed following an internal investigation at the Pennine Acute Hospital NHS Trust. This trust manages the North Manchester General Hospital, Royal Oldham Hospital, Fairfield General Hospital, Rochdale Infirmary, Floyd Unit and various community services.


The report sadly outlines a number of avoidable deaths and long-term injuries caused by failures including staff shortages, clinical errors and poor attitude of staff. It has been reported that the Pennine Acute Hospital NHS Trust received the most legal claims and paid the most in damages out of all NHS Trusts between 2010 and 2015. Sadly nearly half of those claims related to harm caused to mothers and babies.


At Freeths LLP our specialist Clinical Negligence team have years of experience and expertise in dealing with injuries to mothers and babies caused during pregnancy, labour, and following birth. We pride ourselves on our specialist, empathetic and personable legal services for those families facing such difficult circumstances.


Our friendly specialist team work from a number of nationwide offices including our central Manchester office, which is easily accessible and close to Piccadilly Gardens. We also offer home visits.


If you feel that you, or a loved one, may have suffered harm due to poor medical care during pregnancy, labour or following birth we may be able to help you. Please contact Claire Cooper on 0845 274 6830 or Naomi Solomon on 0845 030 5742.

Naomi Solomon
Solicitor
+44(0)845 274 6830
naomi.solomon@freeths.co.uk

 

Claire Cooper
Solicitor
+44(0)845 274 6830
claire.cooper@freeths.co.uk

Safety fears in 2/3 of English A&E departments

Written by Clinical Negligence on October 31, 2016

The Care Quality Commission review has revealed that emergency care in England was one of the poorest performing parts of the NHS, caused majorly by underfunding of council care services.

Safety was cited as a major weakness of emergency care departments with 22 out of 184 units being rated as inadequate and another 95 requiring improvements in their workings. The Care Quality Commission explained that the cuts to council provided care, such as access to home help for daily living tasks, such as dressing and washing, was pushing the elderly and infirm into hospital.

The chief executive of the Care Quality Commission, David Behan, said that the state of the council care system was the worst that he could remember during his 38 year career. He said that things had reached a tipping point and called upon ministers to invest more into the council care system. Numbers of elderly people having care needs has sharply risen, and around 1 million get no help at all.

You can read more about the issues here.

If you, or anyone you know has had issues with emergency care in hospital, please contact Naomi Solomon.

Naomi Solomon

Solicitor

+44(0)845 030 5742

naomi.solomon@freeths.co.uk

A Fifth of Bowel and Rectal Cancer Patients Turned Away By GPs

Written by Clinical Negligence on October 26, 2016

It has been revealed that a fifth of bowel cancer patients were turned away by their GPs upon initial presentation of symptoms. Typical symptoms include abdominal pain, blood in stools, weight loss, and a change in bowel habit, none of which were being followed up by GPs.

Health PHOTO CMYK 300dpiThe British Journal of Cancer in a study noted that patients had seen their GP at least three or more times with relevant symptoms before being officially diagnosed. 35% of bowel cancers and 15% of rectal cancers were only diagnosed after an emergency visit to hospital. Furthermore, 17.5% of colon cancer patients and 23% rectal cancer patients had red flag symptoms which should have been clear to GPs.

There have been calls for specially trained nurses to support GPs and act as a safety net while consultations take place. The study also called for GPs to have better access to specialist advice, as most patients visited their GP in the year before their diagnosis, with many going in the months and days leading up to diagnosis.

More information about the study can be found here.

If you have any queries regarding concerns for your treatment or diagnosis of bowel or rectal cancer, please contact Karen Reynolds.

Karen Reynolds

Partner

+44(0)845 272 5677

karen.reynolds@freeths.co.uk

AvMA cautiously welcome new Department of Health maternity safety and compensation proposals

Written by Clinical Negligence on October 21, 2016

A safer, revised national maternity care action plan was announced by the Health Secretary this week, however, it has been cautiously welcomed by Action against Medical Accidents.

A consultation is to be held on a new rapid resolution and redress scheme which would investigate and learn lessons from more than 500 cases a year. Families would be able to have access to financial support without having to enter a formal legal process, however, this option is still available. If successful, the compensation system would offer support and regular payments. The support would consist of counselling, case management and legal advice.

AvMA chief executive Peter Walsh said:

“It is imperative that safety is improved to prevent these dreadful mistakes happening so often, so we welcome the added impetus to that…However, this also comes with a big health warning. The devil will be in the detail of these proposals. It is essential that any scheme compensates people fairly according to their individual needs rather than short changing them in return for a ‘quick’ settlement…We do not want people to feel pressurised into accepting something less than they need and deserve just to save the NHS money.”

Resources will be provided to Trusts to improve approaches to maternity safety including an £8m fund for maternity safety training with £40,000 available to each English NHS Trust. The plan further includes a £250,000 maternity safety innovation fund, the publication of new local maternity ratings, a national maternal and neonatal health quality improvement programme for Trusts to share best practice and the Healthcare Safety Investigation Branch, to be up and running from April 2017.

Further details on the proposed reform and compensation scheme are awaited from the Health Secretary. While focus on swift redress is welcomed, prevention is always better than a cure.

If you or any woman you know has been affected by issues surrounding antenatal care, birth or post-partum care, please contact Karen Reynolds.

Karen Reynolds
Partner
+44(0)845 272 5677
karen.reynolds@freeths.co.uk