If you have had heart surgery in the last four years, you may have been exposed to serious risks. A recall was issued for a medical device sometimes used during heart surgery. The device is under investigation for causing bacterial infections, serious illnesses, and accidental deaths.
The Stockert 3T Heater – Cooler is a medical device which was originally developed by the Sorin group but today is owned and manufactured by LivaNova. It has recently been the subject of multiple lawsuits since having been linked to bacterial infections causing serious illnesses and sometimes death.
The Stockert 3T Heater – Cooler works to regulate a patient’s body temperature during surgery, particularly during open heart procedures. The device works by feeding water from a temperature controlled chamber through tubes to either a heat exchanger, or a blanket through closed circuits. At no point does the water inside the unit come into contact with the patient.
The Food and Drug Administration (FDA) has issued warnings of the correlation between use of heater-cooler devices and infection by a nontuberculous mycobacteria (NTM) called M. Chimaera.
In 2015, the FDA and the Center for Disease Control and Prevention (CDC) both issued warnings linking the Stockert 3T heater cooler to harmful bacterial infection. In 2016, the FDA again issued an even stronger warning to LivaNova that they had failed to adequately validate and verify the disinfecting and cleaning process for the machines. The environment of the water inside these machines is ideal for colonization of NTM which can become airborne via the venting mechanism of the unit. When open chest cardiothoracic surgery is taking place next to the unit, the now airborne bacteria can infect the surgical cavity leading to a potentially fatal infection. In response to the FDA warnings, LivaNova issued an update to consumers stating:
Consistent with these communications, LivaNova and its representatives will proactively and voluntarily contact facilities to facilitate implementation of the CDC and FDA recommendations that:
- Heater-cooler devices known or suspected to be contaminated with NTM, based on the facility’s testing program or other information known to the hospital, should be removed from service.
- Heater-cooler devices manufactured before September 2014 (refer to Attachment 4 for the affected catalogue and serial numbers) should only be used as directed by the FDA Safety Communication.
- Heater-cooler devices that are not known or suspected to be contaminated and manufactured during or after September 2014 and should be used in accordance with the Operating Instructions and take into account additional precautions specified in the FDA Safety Communication. a.) Following the Operating Instructions for heater-cooler devices and specifically those relating to cleaning and disinfecting. We continue to believe that following these operating instructions is essential to mitigating the potential risk posed by using these non-sterile devices. The FDA Safety Communication confirms the importance of following the applicable operating instructions. b.) Conducting water quality monitoring per Ivanovo’s June 2015 3T Field Safety Notice “Cardiac Surgery Mycobacterium Risks.”
The FDA and the CDC report that some of these devices became contaminated with the deadly bacteria during their production at a facility in Germany. Failure to properly disinfect and maintain the units, however, seems to have had a direct impact of the proliferation of the bacteria and the risk to the patient during surgery. – Source
Death Toll Could Continue to Rise
Between 2010 and 2015 the FDA has been aware of 32 cases of M. Chimaera, of those 32 cases almost half of the infected have died. One healthcare information journal puts the number of infections even higher, stating in an article written in July of this year:
“M. chimaera is exceedingly difficult to detect, treat, and eradicate from devices, shrugging off both antibiotics in humans and powerful disinfectants in machines. It subsequently emerges in post-surgical patients as a slow-growing but potentially fatal infection that may not become symptomatic for a year or more. Though there have been only an estimated 65 to 70 documented cases in the U.S. and Europe, it is a given that more cases are being missed because of the difficulty in detecting infections that appear far removed from the surgical exposure.”
In light of the fact that these devices have been and are still being used in hundreds of thousands of cardiothoracic surgeries in the U.S. annually, and that the bacteria is slow to show symptoms, these numbers could continue to rise for years to come.
The CDC warns patients who may have come into contact with the device that the symptoms of NTM infection including M. chimaera infection can take months to appear and that patients should be aware of the following symptoms:
- persistent or unexplained fever
- night sweats
- redness, heat, or pus around a surgical incision
- muscle aches
- unexplained weight loss
- fatigue
They further state, “Patients who have had cardiac surgery should seek medical evaluation if they have one or more of these symptoms or have questions about possible exposure to a heater-cooler device.” Source: CDC
The FDA lists additional symptoms to be aware of:
- difficulty breathing
- persistent cough or cough with blood
- pain
- muscle pain
- joint pain
- abdominal pain
- nausea
- vomiting
The FDA has provided additional information for patients on their Heater-Cooler Devices “Information for Patients” webpage.
Hughes & Coleman Injury Lawyers has recently begun offering free legal consultations for people who may have come into contact with this machine during a medical procedure and who may be showing symptoms of the infection. Numerous lawsuits have already been brought against the LivaNova company and against the hospitals responsible for the cleaning and disinfecting of these devices. Hughes & Coleman will be happy to discuss your case with you.
