Events

Safety Alert for PLUM LifeCare 5000 Series and PLUM XL Families of Infusers

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
    2013-12-12
  • Event Date Posted
    2013-12-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131212.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: hospiraplum lifecare 5000 series and plum xl families of infusers the australia therapeutic goods administration (tga) posted a medical device safety alert concerning plum lifecare 5000 series and plum xl families of infusers manufactured by hospira inc.The affected products are identified as follows:- plum lifecare 5000, list number: 02507 plum xl, list number :11555 plum xlm, list number: 11846 plum xld, list number: 11859 the door roller assembly on the plum a lifecare 5000 series and plum xl has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the iv administration set's cassette from the pump. the manufacturer is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: open the cassette door by pulling on the lever; unlatch the cassette door by pushing on the door release tab and pulling the door down; visually inspect the door roller pin for any evidence of the damage or door roller misalignment; and ensure that the door roller spins smoothly with a finger touch. if any door rollers or pins appear loose, broken or missing, hospira advises users to remove the device from use. the manufacturer is in the process of retiring the plum lifecare 5000 and plum xl in 2015. for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01288-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 december 2013.

Device

PLUM LifeCare 5000 Series and PLUM XL Families of Infusers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HospiraPLUM LifeCare 5000 Series and PLUM XL Families of Infusers
  • Manufacturer
    Hospira Inc

Manufacturer

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