Events

Safety Alert for Alaris Pump Module, Model 8100

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CareFusion 303.

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
    2012-08-24
  • Event Date Posted
    2012-08-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120824.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, model 8100 the united states food and drug administration (fda) has issued a class i recall concerning alaris pump module, model 8100, manufactured by carefusion 303, inc. the manufacturer has identified a potential risk associated with the alaris pump module model 8100. carefusion has received reports of customers experiencing motor stalls during infusion with alaris pump module (model 8100) manufactured between august 2010 and july 2011. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following websites http://www.Accessdata.Fda.Gov/scripts/enforcement/ enforce_rpt-event-detail.Cfm?action=detail&id=55121&w= 08222012&lang=eng http://www.Carefusion.Com/customer-support/alerts-notices/ medical-device-recall-alaris-pump-module-8100-intermittent-motor- stall.Aspx. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 august 2012.

Device

Alaris Pump Module, Model 8100

Manufacturer

CareFusion 303