Events

Safety Alert for LifeCare PCA Infusion System

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

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
    2012-09-11
  • Event Date Posted
    2012-09-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911b.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hospira lifecare pca infusion system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning lifecare pca infusion system, manufactured by hospira, inc. the manufacturer has received customer reports related to improper use of the slide clamp when the syringe (vial) is manipulated, or when stopping the infusion during delivery of medication. failure to close the slide clamp whilst manipulating the syringe (vial) or stopping the infusion, may result in an over delivery of the medication being infused which has the potential to cause a life threatening/critical injury to the patient. furthermore, the manufacturer advised users to follow the labelled instructions for the correct use of the slide clamp when manipulating the syringe (vial) or when stopping infusion during delivery of fluids. hospira is in the process of creating cautionary labels for the pca device, which will alert clinicians to close the slide clamp prior to handling the pca vial and to open the slide clamp before starting therapy. the manufacturer is also investigating whether a design improvement is feasible to further mitigate this risk. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

LifeCare PCA Infusion System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira LifeCare PCA Infusion System
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DH