Events

Recall of PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hospira Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01288-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01288-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
    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
  • Reason
    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.
  • Action
    Hospira 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. -Ensure that the door roller spins smoothly with a finger touch. If any door rollers or pins appear losse, broken or missing, Hospira is advising to remove the device from use. Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015.

Device

PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA