Company: CareFusion 303, Inc.
Date of Enforcement Report:4/23/2014
Class I:
PRODUCT
Alaris Pump Module (Model 8100), Software Version 9.1.18
The Alaris Pump Model 8100 is a large volume infusion pump. It is intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic (intermittent) delivery through various routes such as under the skin. The Alaris pump is used for adults, children, and newborns.
REASON
CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because it may have a software failure where the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used. The firm received one report where the device malfunctioned when the ?Delay Until? option was selected.
The software failure also causes the pump to not properly deliver a multidose infusion as expected under the following conditions:
When the first dose is programmed to infuse when the system time is earlier than 7 pm (19:00) and a subsequent dose is intended to infuse between 19:00 and 11:59 pm (23:59); and
When the first dose is programmed to infuse when the system time is between 19:00 and 23:59 and a subsequent dose is intended to infuse between 12 am (00:00) and 6:59 pm (18:59) the next day.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, California.
FDA District: Los Angeles District Office
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