Events

Safety Alert for Plum-Set IV Administration Sets

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

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
    2013-09-03
  • Event Date Posted
    2013-09-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130903.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 plum-set iv administration sets the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning plum-set iv administration sets for infusion pump and intravenous & blood transfusion, manufactured by hospira inc. all lots manufactured after july 2007 are affected. hospira has received reports, including one that resulted in a serious injury, of fluid leaking at the clave secondary port of hospira plum-set iv administration sets during infusion due to the breaking of the bond between the clave and the secondary port of the plum cassettes. the breaking of the bond can manifest itself as either cracking of the bond between the clave and the secondary port or the complete separation of the clave from the secondary port. breakage of the connection or leaking of fluid may result in a delay of therapy and subsequently lead to death or permanent injury if the therapy is life-sustaining. moreover, leakage of a caustic substance such as an oncolytic can result in short term harms such as pain or chemical burns, or long term harm such as tissue necrosis. in order to minimize the possibility of separation or breakage of the clave directly bonded to the secondary port of the plum cassette, hospira recommends users to follow the instructions below: do not twist or bend the clave when accessing the secondary port. ensure all instructions for use are completely followed. ensure local protocol for administering fluids and blood products are completely followed. in addition, hospira will update the instructions for use of the device to reflect the above recommendations and will also be working to determine a different method by which the clave can be bonded to the secondary port of plum cassettes. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con309602 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 september 2013.

Device

Plum-Set IV Administration Sets
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Plum-Set IV Administration Sets
  • Manufacturer
    Hospira Inc

Manufacturer

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