The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Alaris Pump Module (Model 8100) with software version 9.1.18 manufactured by CareFusion Inc. The affected devices were manufactured from 6 February, 2014 to 8 April, 2014 and distributed from 7 February, 2014 through 7 April, 2014.
The manufacturer 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:
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.
The manufacturer advises users not to use the Alaris Pump module "Delay Until" option and not to use the "Multidose" feature. Furthermore, the manufacturer will contact all affected customers to schedule the installation of software version 9.1.17. 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.
For details, please refer to the following FDA website:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398178.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 May 2014