Device product
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Z-1099-2019
Product summary
- Event
- Event 82365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 devices
- Official record key
device-enforcement:Z-1099-2019
Official wording
Reason: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
Code information: Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Distribution pattern: US Distribution to states of: IN, MO, and OH.
Derived failure modes
-
Unknown
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).