Events

Recall of Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pump with Hospital MedNet Software

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-2012-RN-01281-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01281-1
  • 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+/a+3 infuser family of infusers 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 will fit a redesigned roller door to reduce the potential for the roller door assembly to break. Until the correction can be made Hospira is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Unlatch the cassette door from the opener handle assembly by pushing on the door release tab and open the door fully. -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.

Device

Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pum...
  • Model / Serial
    Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pump with Hospital MedNet SoftwarePlum A+ Infusion PumpList number: 12391, 11971Plum A+ Infusion Pump with Hospira MedNet SoftwareList number: 20792Plum A+3 Infusion Pump with Hospira MedNet SoftwareList number: 20678ARTG Number: 138109
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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