Device product
0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Z-0944-2019
Product summary
- Event
- Event 81375
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0944-2019
Official wording
Reason: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Code information: 74A1801899 74H1602701 74B1700146 74L1700201 74B1700921
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.