Device product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Z-2179-2025
Product summary
- Event
- Event 97067
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 33,162,680 units total
- Official record key
device-enforcement:Z-2179-2025
Official wording
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Code information: BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
Distribution pattern: US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey
Derived failure modes
-
Unknown
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.