Device product
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Z-1498-2020
Product summary
- Event
- Event 85098
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total Worldwide=9309 systems (2713 system in U.S.)
- Official record key
device-enforcement:Z-1498-2020
Official wording
Reason: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Code information: Device Listing: E572259 Product Code Product Description Affected Serial Number range 16-02-80 Heater-Cooler 3T, 230V 16S10027 16S16874 16-02-81 Heater-Cooler 3T, 240V 16S10743 16S11708 16-02-82 Heater-Cooler 3T, 208V 16S10772 16S16840 16-02-83 Heater-Cooler 3T, 127V 16S11455 16S16509 16-02-85 Heater-Cooler 3T, 120V 16S10958 16S16847 16-02-95 Heater-Cooler 3T, 200V 16S12004 16S16818
Distribution pattern: U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
Derived failure modes
-
Unknown
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.