Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose"

FDA device recall Z-1567-2014 · posted 2014-05-14 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

Action taken

CareFusion sent an Urgent Medical Device Recall Notification letter dated April 23, 2014, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician this could result in serious injury or death. Customers are informed although no adverse events or deaths have been reported there is a potential for this risk. If customers experience the issue while using the Alaris Pump module then they are instructed to contact CareFusion Customer Advocacy at (888) 812-3266. Customers are instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process. For questions regarding this recall call 858-617-4000.

Root cause

Software design

Status

Terminated

Product code

FRN

Quantity affected

57,219 units total (55,756 units in US)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.

Date initiated

2014-04-23

Date posted

2014-05-14

Date terminated

2017-03-01

Location

San Diego, CA

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