Events

Safety Alert for Alaris Pump Module

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CareFusion Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-05-21
  • Event Date Posted
    2014-05-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140521a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: carefusion alaris pump module 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: 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. 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.

Device

Alaris Pump Module

Manufacturer

CareFusion Inc