Recall – Infusion pump with multiple software errors

Company: CareFusion 303, Inc.
Date of Enforcement Report: 3/11/2020
Class I

PRODUCT

CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

  • Recall Number: Z-1359-2020

REASON

1)Error 255-XX-XXX results in inability to edit settings

2)Delay options programming may result in no KVO rate/therapy interruption

3)Software errors results in no low battery alarm/infusion stopping

4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion

5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders.

 

RECALLING FIRM/MANUFACTURER

CareFusion 303, Inc. on 2/4/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

870070

DISTRIBUTION

US Nationwide and International

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