Recall Z-1309-2021 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
| Date | Mar 3, 2021 |
| Status | Open, Classified |
| Reason | Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay |
| Root cause | Process design |
| Action | On 03/03/2021, Medical Device Recall notices were mailed to customers including, Directors of Biomedical Engineering, Directors of Nursing, and Directors of Risk Management. Customers were asked to return the customer response form and were advised of the following: If you had previously remediated devices affected by the August 4, 2020 Pump Module Keypad Recall, those devices will not need to be remediated a second time, as a result of this recall. If Pump Module keypad lifting or stuck or unresponsive keys are observed, remove the pump from service and send to Biomedical Engineering. If |
| Quantity | 160300 |
| Distribution | Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |