Recall Z-0530-2022 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
| Date | Jan 29, 2022 (initiated Dec 29, 2021) |
| Status | Open, Classified |
| Reason | There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps. |
| Root cause | Device Design |
| Action | The firm sent URGENT SAFETY COMMUNICATION letters on 12/29/2021 via first class mail, addressed to Directors of Biomedical Engineering, Risk Management, Nursing, and Nurse Educators. The letter described the problem, the affected product (Spectrum V8 and Spectrum IQ infusion pumps), hazard involved, and the actions to be taken by customers. Acknowledge receipt on customer portal https://BaxterFieldActionCustomerPortal.onprocess.com/. Follow on-screen instructions, infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections, and upstream occlusion alar |
| Quantity | 146,502 units |
| Distribution | Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation, May 7, 2014 |