Events

Safety Alert for CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL

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

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
    2015-05-12
  • Event Date Posted
    2015-05-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150512.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: baxter healthcare ce infusor patient control module watch (pcm), 0.5 ml medicines and healthcare products regulatory agency (mhra), united kingdom, posted a medical device safety alert concerning ce infusor patient control module watch (pcm), 0.5 ml [product code: 2c1079k. lot number: 13m061. expiry date: 30 nov 2016] manufactured by baxter healthcare. the manufacturer received complaints that reported leak in the reservoir. this issue is being investigated and only affects the 0.5 ml pcm watch. the leak in the reservoir may lead to medication contamination, which could result in infection or other serious adverse health consequences. product recall is on-going. according to the local supplier, the affected lot is not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 may 2015.

Device

CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare