FDARecall Class:  Class I

Date Recall Initiated:  April 23, 2014

Product: Alaris Pump Module (Model 8100), Software Version 9.1.18

Affected Serial Numbers

The affected products were manufactured From February 6, 2014 to April 8, 2014 and distributed from February 7, 2014 through April 7, 2014.
This issue does not impact the “Delay For” Option.

Use: 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.

Recalling Firm: 
CareFusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego, California  92121-4386

Reason for Recall: 
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.

Affected customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician, serious injury or death could result.

To learn more and to access contact information regarding this recall, click here.