Events

Recall of All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet Software

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

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-00189-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00189-1
  • 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
    There is a potential for the distal (occlusion) pressure sensor pin to break on plum a+ infusers. the distal pressure sensor pin is part of the overall subsystem that measures the pressure within the distal line of the administration set and indicated the presence of a full or partial distal occlusion. a broken distal pressure pin can only be detected via a visual inspection of the distal pressure pin.
  • Action
    Hospira has provided work around instructions in the customer letter to identify and mitigate the issue temporarily.To further address this issue, Hospira is in the process of redesigning the distal pressure sensor pin to improve its strength and reduce the potential for breakage. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption of therapy or an under/over-infusion could result in serious injury or death.

Device

All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pum...
  • Model / Serial
    All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet SoftwarePlum A+Single Channel Infusion PumpCatalogue Number: 611239101Number on Pump: 12391 & 11971Plum A+ Infusion Pump with MedNet SoftwareCatalogue Number: 612079201Number on Pump: 20792Plum A+3 Infusion Pump with MedNet SoftwareCatalogue Number: 612067801Number on Pump: 20678
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Australia Pty Ltd

Manufacturer

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