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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump model 8100

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 Class 1 Device Recall Alaris Pump model 8100 see related information
Date Posted May 14, 2014
Recall Status1 Open
Recall Number Z-1567-2014
Recall Event ID 68066
510(K)Number K950419 
Product Classification Pump, infusion - Product Code FRN
Product 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.
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Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-4000
Manufacturer 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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 57,219 units total (55,756 units in US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IMED CORP.
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