FDA Device

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Hazard

There is a potential software error during programming.

What You Should Do

Remedy

A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.

Products

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Brand
Baxter Healthcare Corporation
UPC
Product Code 35700ABB, GTIN 00085412091570

Units Affected

9,353 devices