Device product
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Z-1076-2024
Product summary
- Event
- Event 93849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16520 worldwide; 6657 US
- Official record key
device-enforcement:Z-1076-2024
Official wording
Reason: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Code information: UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Sterility assurance
compromised sterile barrier