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
    2012-08-23
  • Event Date Posted
    2012-08-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120823.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 (formerly medley pump module), manufactured by carefusion 303, inc. the manufacturer had identified that there is a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly with keypad part number tc10005926. this could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. when infusion stops, serious injury or death may result. customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. for details, please refer to the following fda websites http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm316612.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm316637.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 august 2012.

Device

Alaris Pump Module, Model 8100

Manufacturer

CareFusion 303