Events

Safety Alert for COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7

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
    2015-05-08
  • Event Date Posted
    2015-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150508.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 colleague single channel cxe pump, v1 .7 medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning colleague single channel cxe pump, v1.7 with item code 2m91617 and serial number 21010369dl. according to the safety alert, the issue is related to the use of an incorrect user interface module (uim) during service. the use of the incorrect spare part could lead to a pump shutdown without an alarm (silent shutdown) if the uim printed circuit board assembly fails. this defect could occur before starting or during therapy that could potentially cause a delay of infusion or interruption of infusion. according to the local supplier, the affected products are distributed in hong kong. the manufacturer will collect the affected device for correction. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 may 2015.

Device

COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare