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Articles Product Liability 14th Jul 2017

Latest research confirms Mycobacterium Chimaera infection from LivaNova / Sorin / Stockert heater cooler units

The latest piece of research into the outbreak of Mycobacterium Chimaera (M. Chimaera) has been published in the Lancet: Infectious Diseases on 12 July 2017. The paper “Global outbreak of severe Mycobacterium Chimaera disease after cardiac surgery: a molecular epidemiological study” sets out the findings of a molecular epidemiological investigation carried out to establish the source of the Mycobacterium Chimaera (M. Chimaera) infection found in patients who have undergone cardiac surgery.

The study of 250 samples tested from cardiac surgery patients concluded that: “the LivaNova factory seems a likely source for cardiothoracic surgery-related severe M Chimaera infections diagnosed in Switzerland, Germany, the Netherlands, the UK the USA and Australia”.

The study therefore confirms previous reports concluding that the Mycobacterium Chimaera (M. Chimaera) infection originates from the German production line manufacturing LivaNova heater cooler units originally sold under the Sorin 3T and Stockert 3T brand names.

These heater cooler units are commonly used during cardiothoracic procedures such as coronary bypass or valve replacement operations. The Mycobacterium lies dormant in these units until aerosolised during operations and entering the body. The manufacturers have revised the design of the units. Operating theatre staff now adopt stringent disinfectant regimes and try and site the units as far from the operating table as is possible.

The cluster of cases of Mycobacterium chimaera first came to public health authorities worldwide following Swiss research culminating in 2012 but in this country it was not until March 2017 that the medical profession generally and potentially affected patients were notified of the risk and what to look out for. At that time Public Health England reported that there had been 28 confirmed cases in England including 15 patients who had died. The latest death of a cardiac patient infected with Mycobacterium chimaera occurred the day this latest research paper was published.

Symptoms of Mycobacterium Chimaera (M. Chimaera) arise any time between 3 months to five years after the cardiac operation and include:

  • 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

We have presented claims for compensation to the manufacturers of the Sorin 3T/Stockert 3T heater cooler units on behalf of a number of cardiac patients who contracted Mycobacterium Chimaera (M. Chimaera) infection from the contaminated heater cooler units.

If you have been diagnosed with Mycobacterium Chimaera (M. Chimaera) infection and seek advice on bringing a claim, please do not hesitate to contact Paul Balen on 0845 050 3289 or James Cavanagh on 01865 781 193.

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30324-9/fulltext?elsca1=tlpr


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