New Jersey patient says Terumo-made heater-cooler unit allowed life-threatening bacteria into surgical theater.
By Laurence Banville
Japanese medical device manufacturer Terumo and the University of Pennsylvania have been hit with a new heater-cooler lawsuit, Mass Device reports. In her complaint, filed in the Philadelphia County Court of Common Pleas, a 39-year-old woman from New Jersey says she contracted a "devastating" bacterial infection during a 2016 open heart surgery. Terumo's HX2 heater-cooler, a machine used to regulate a patient's body temperature during cardiac bypass procedures, was used in the operation.
Bacterial Outbreaks Trace Back To Surgical DeviceTerumo "ignored" years of warnings from the global medical community, attorneys for the plaintiff say. Health regulators around the world have been worried about the safety of heater-cooler units for some time. Terumo, however, doesn't seem to have taken heed of these "red flags," the plaintiff writes. She accuses the company of failing to take the steps necessary to improve the safety of its product, while continuing to advertise the machine as safe and effective. The Hospital of the University of Pennsylvania, plaintiff claims, had received "early warning signs" that Terumo's heater-cooler device could increase the chances of a life-threatening infection, but failed to change its surgical policies.
LivaNova 3T Units Linked To Most InfectionsTerumo isn't the most notable manufacturer of heater-cooler devices. That dubious honor goes to LivaNova, a company formerly known as Sorin that makes the 3T Heater-Cooler (which, confusingly, used to be called the Stöckert 3T). Name changes aside, the device itself is largely unchanged.
As the world's leading heater-cooler model, 3T units are employed in up to 60% of all the cardiac bypass surgeries performed in the United States. Unsurprisingly, the vast majority of bacterial infections linked to these devices have been traced back to machines manufactured by LivaNova. In fact, recent investigations spearheaded by the Food & Drug Administration suggest that many, if not most, 3T heater-coolers were contaminated with bacteria during the manufacturing process, not after their sale to hospitals. Federal health regulators have restricted imports of the device until LivaNova can assure more stringent safety testing.
50% Of Heater-Cooler Units May Be ContaminatedNew testing out of the Special Pathogens Laboratory has found that up to 50% of heater-cooler units may be contaminated with some strain of Nontuberculous Mycobacterium. 1 in 3 units appear to be harboring a single variant of the bacterium: M. chimaera.
At least 16 patients who contracted Nontuberculous Mycobacteria infections during bypass procedures have already filed lawsuits against LivaNova, accusing the company of endangering public health.
The device, these patients claim, is defective, both in design and manufacturing, allowing potentially-fatal bacteria to spread unchecked during surgery. Noting that informal coordination efforts have proven sufficient so far, the Judicial Panel on Multi-District Litigation declined to consolidate the cases in April of 2017. Ten of the pending lawsuits have already been assigned to the same district judge in South Carolina.