Recall Z-0123-2024 ยท FRN Pump, Infusion
B. Braun Medical, Inc.
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
| Date | Oct 25, 2023 (initiated Sep 21, 2023) |
| Status | Open, Classified |
| Reason | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death. |
| Root cause | Component design/selection |
| Action | On September 21, 2023, the firm began notifying customers of the issue via "URGENT MEDICAL DEVICE CORRECTION" letters. BBMI will schedule service to update impacted devices. Customers were provided with stickers to identify affected units while waiting for the service to be completed. In the meantime, customers were informed of measures that may aid in continued use of the pumps, such as only using non-impacted devices for the delivery of high-risk medications and placing the impacted units in care areas that do not administer high risk medications. Customers may contact BBMI by calling 1-8 |
| Quantity | 9771 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |