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Terminated

Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

FDA Recall Z-1567-2014 · Posted 2014-05-14

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2014-04-23
Date Terminated2017-03-01
Product Quantity57,219 units total (55,756 units in US)

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.

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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