On November 30, 2015, a husband and wife filed a notice of medical negligence claim against a Pennsylvania hospital regarding the husband’s open heart surgery in November 2013 that allegedly resulted in him contracting a very serious bacterial infection due to an allegedly unclean device used during his surgery.
The man’s notice of medical negligence claim reportedly states that he “was exposed to nontuberculous mycobacteria [NTM] via a very poorly cleaned heater/cooler machine used during surgery.” The heater-cooler device was manufactured by Sorin Group, which is based in Germany, and the devices have been linked to similar infections in another Pennsylvania hospital and in Europe.
On October 26, 2015, the Pennsylvania hospital announced that it recently began notifying approximately 1,300 open-heart surgery patients of possible exposure to bacteria during open-heart surgery procedures at the hospital that were performed between October 1, 2011 and July 24, 2015, encouraging them to consult their primary care physician who can help them monitor their health and identify any new symptoms that could be associated with a possible NTM infection – particularly within four years following the date of their most recent open-heart surgery at the hospital.
The hospital stated that a study published in July 2015 in the medical journal Clinical Infectious Diseases that was based on evidence from patient cases in Europe alerted the hospital’s infectious disease specialists to a previously unknown risk of infection through aerosolized NTM bacteria escaping from the heater-cooler devices that are used during open-heart surgery, which could pose a risk to patients who are on heart bypass machines with heater-cooler devices during surgery.
Shortly after it became aware of the study, the hospital’s staff became aware of several surgery patients with NTM infections of the type identified in the study, and subsequently the CDC determined that the NTM infections identified in the hospital’s patients are likely linked to the heater-cooler devices, paralleling the findings of the European study. The CDC advised the hospital of its findings on October 15, 2015, after which the hospital identified eight probable cases of NTM infections in patients who underwent open-heart surgery at the hospital (the NTM infections were identified months or years following their surgery).
Four of the eight patients had died. The hospital stated that the CDC had not directly linked the four deaths to the NTM infections associated with the heater-cooler devices, but that it is likely a contributing factor.
The hospital further stated that it had completely replaced its heater-cooler devices with new equipment in late July 2015. The hospital also found that its cleaning protocols for the heater-cooler devices did not align perfectly with the original guidelines provided by the device manufacturer, which recently alerted customers across the United States of enhanced cleaning procedures to address NTM contamination concerns.
If you or a loved one were seriously injured (or worse) due to a heater-cooler device in the United States, you should promptly find a defective medical device claim lawyer who may investigate your heater-cooler device claim for you and represent you in a claim for compensation due to the harm you or your loved one suffered as a result of a defective heater-cooler device.
Turn to us when you don’t know where to turn.