Recall Z-2939-2020 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
| Date | Aug 4, 2020 |
| Status | Open, Classified |
| Reason | Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations. |
| Root cause | Device Design |
| Action | On August 4, 2020, the firm notified affected customers via mail, "Urgent Medical Device Recall", indicating the following: Actions for Clinical Users: Clinicians should remove the pump from service and send to Biomedical Engineering if the Pump Module keypad becomes unresponsive or stuck. If a critical medication is being administered, continue the infusion until it is safe to replace the Pump Module. In an urgent situation, clinicians can close the roller clamp on the IV administration set to stop an infusion. Actions for Cleaning Personnel: Follow the cleaning instructions provided in the |
| Quantity | 248,519 |
| Distribution | Worldwide: US* (AK, AL, AR, 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, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary |
| 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 |