Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- September 28, 2016
- Terminated
- June 15, 2018
- Recall Number
- Z-0671-2017
- Quantity
- 15,517 units (US: 9560; Canada: 5957)
- Firm Location
- Deerfield, IL
Reason for Recall
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Distribution
Nationwide Distribution, Puerto Rico and Canada
Lot / Code Info
Contact CDRH for list of affected serial numbers (15,517).
Root Cause
Process control
Action Taken
Baxter sent an Urgent Medical Device Correction letter dated September 28, 2016, to all affected customers. On 10/27/2016, Baxter Healthcare sent a f/u UMDC Letter (dated 10/27/2016) to customers. The f/u letter contains the device correction plan which states that Baxter will be replacing at no charge the rear case assembly on all affected Sigma Spectrum Infusion Pumps, as well as affected stand-alone rear case assemblies shipped to customers as spare parts. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.