Recall Z-2103-2023 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
| Date | Jul 13, 2023 (initiated Jun 15, 2023) |
| Status | Open, Classified |
| Reason | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01. |
| Root cause | Under Investigation by firm |
| Action | Customers were contacted via phone and email beginning on June 2, 2023. An Urgent Medical Device communication was sent to all affected customers on June 15, 2023, via U.S.P.S., first class mail. The notice explained the problem, the risk involved, and requested the following: "Actions to be taken by Customers: 1. Operators may continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions, or the infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of t |
| Quantity | 3306 units |
| Distribution | US Nationwide distribution. |
| 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 |