October 24, 2016 — Maquet Medical Systems is warning that its surgical heater-cooler units “might be contaminated” with mycobacteria, but said no patient infections have been reported.
Last week, the FDA warned about deadly mycobacterial infections from the LivaNova Stӧckert 3T heater-cooler, which is used in about 150,000 open-heart surgeries per year.
Maquet issued a Field Safety Notice (PDF) on August 22, warning hospitals about the presence of Non-Tuberculosis Mycobacterial (NTM) contamination — and other bacterial contamination — in the water in heater-cooler devices used during open-heart surgery.
Maquet has received no reports of adverse events, diseases, or illnesses associated with Mycobacteria contamination. However, the company asks hospitals to disinfect contaminated heater-cooler units.
The warning includes all models and all serial numbers of the following devices:
- Heater Unit HU 35
- Heater-Cooler Unit HCU 20
- Heater-Cooler Unit HCU 30
- Heater-Cooler Unit HCU 40
Heater-cooler machines pump water into a special blanket to control the body temperature of patient who is under anesthesia during open-heart surgery. Water in the system does not come into direct contact with the patient, but contaminated water can potentially enter other parts of the device and spray bacteria through the air (aerosolize) from the exhaust vents and onto a patient.