Device product

SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

Z-2103-2023

June 15, 2023

Class I

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 92562
Status: Ongoing
Classification: Class I
Quantity: 3306 units
Official record key: device-enforcement:Z-2103-2023

Official wording

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.

Code information: GTIN 00085412498683, Software version v8.01.01, Serial Numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.