Recall Z-2581-2024 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
| Date | Aug 16, 2024 (initiated Jul 17, 2024) |
| Status | Open, Classified |
| Reason | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/16/2024 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps. If clinicians observe a lack of auto-documentation within the flow sheet or medication administration record, they should verify medication was given, and document in the EMR as if manually programming the pump. The pump will need to be programmed manually rather than through auto-programming |
| Quantity | 17,377 units |
| Distribution | US, Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation, Mar 31, 2023 |