Events

Safety Alert for INFUSOR Portable Elastomeric Infusion System

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

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
    2014-03-05
  • Event Date Posted
    2014-03-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140305.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 infusor portable elastomeric infusion system medical device manufacturer, baxter healthcare sa has issued a medical device safety alert concerning infusor portable elastomeric infusion system with product codes 2c1071kjp, 2c1075kjp and 2c1976kj. all lot numbers within expiration dating are affected. while there have been no changes made to the product, recent review of flow rate testing has shown that the nominal flow rate as labelled is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20 cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use. if the device is positioned according to the current directions for use, a greater than intended flow rate (up to 4%) may occur. therefore, the manufacturer now advises users to position the infusion system’s elastomeric reservoir 6-8 inches (15-20 cm) below the distal luer lock in order to achieve the labelled flow rate. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 march 2014.

Device

INFUSOR Portable Elastomeric Infusion System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter INFUSOR Portable Elastomeric Infusion System
  • Manufacturer
    Baxter Healthcare SA

Manufacturer

Baxter Healthcare SA