Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion

[Posted 05/21/2014]

AUDIENCE: Risk Manager, Biomedical Engineer, Nursing

ISSUE: CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump 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. This issue does not impact the “Delay For” Option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. See the FDA recall notice for more information.

Infusion start times earlier or later than intended could result in serious injury or death.

BACKGROUND: The Alaris Pump Model 8100 is a large volume infusion pump. The affected products were manufactured from February 6, 2014 to April 8, 2014 and distributed from February 7, 2014 through April 7, 2014. See the FDA recall notice for a listing of the affected serial numbers.

RECOMMENDATION: The firm recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. CareFusion will contact all affected customers to schedule the installation of software version 9.1.17. Do NOT use the Alaris Pump module “Delay Until” option. Do NOT use the “Multidose” feature.

As an interim guidance, customers may update their dataset to disable both Delay Options and/or Multidose across all Profiles to prevent the use of “Delay Until” option and/or “Multidose” feature. These are shared configurations with the Alaris Syringe module and if disabled would prevent use of these features with the Alaris Syringe module as well.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/20/2014 - Recall Notice - FDA]