Heart Surgery Heater-Cooler Infection Problems Could Have Been Avoided
The manufacturers of the 3T Heater Cooler System, which is commonly used to control blood temperaturs during open heart surgery, failed to take basic steps that could have avoided contamination problems.
As a result, individuals throughout the United States have been exposed to a risk of severe and life-threatening heart surgery heater-cooler infections, including M. Chimaera, M. Abscessus and other Nontuberculous Mycobacteria (NTM) infections.
The lawyers at Saiontz & Kirk, P.A. provide free consultations and case evaluations for individuals who believe they may have been exposed to a contaminated heart surgery heater-cooler, or been diagnosed with a debilitating infection that may not surface until months after:
- Cardiac Bypass Surgery
- Valve Replacement Surgery
- Other Open Heart Procedures
Based on information uncovered during the investigation of these cases, it appears increasingly clear that these heart surgery heater-cooler infection problems could have been avoided.
Heart Surgery Heater-Cooler Problems
Illnesses and wrongful deaths reported nationwide could have been prevented if proper disinfecting instructions had been provided, as well as other steps that may have avoided contamination.
An FDA inspection in 2011 found that the company’s original instruction called for the devices to be disinfected every 14 days. However, investigators warned that bacterial overgrowth could occur well in excess of safety standards in just one and a half days.
According to information uncovered in recent months, the manufacturers admitted to FDA investigators that the heater-cooler cleaning instructions were not compliant with U.S. standards, and that it had no data to support the 14 day disinfection instructions it gave to U.S. customers.
The FDA has determined that the manufacturer failed to conduct a proper risk assessment, but the company suggested that the risk of patient infection had not been considered because it was determined to not be of concern.
It would be more than four years before the 3T Heater-Coolers were recalled.
In June 2017, a study presented at the Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC) warned that more than one-third of all 3T Heater Cooler Systems, used in thousands of hospitals worldwide, may be contaminated with M. Chimaera.
The study, conducted by researchers with the Special Pathogens Laboratory between July 2015 and December 2016, looked at 89 different 3T systems, finding 33 of them to be contaminated.
3T Heater Cooler Infection Lawsuits
Due to the defective and unreasonably dangerous design of the 3T Heater-Coolers, together with failure to provide proper warnings and instructions, the system may colonize bacteria and transmit it to heart surgery patients during the invasive procedures.
Financial compensation may be available through heart surgery heater-cooler infection lawsuits since it appears that these problems were avoidable. The manufacturers failed to conduct basic risk assessment and failed to properly instruct hospitals on how to properly disinfect the heater-coolers. Furthermore, the infections appear to track back to the manufacturing facility itself, indicating that bacteria controls were inadequate at the very place the devices were made.
To review a potential case for yourself or a loved one, request a free consultation and claim evaluation.