Events

Recall of Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)

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-01039-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01039-1
  • 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 volume control knob located on the back of the infuser may not function as described in the system operating manual; the direction for loud and quiet may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume, however on some devices the alarm volume increases when the knob is turned clockwise. while the device will continue to alarm with an audible tone of at least 50dba at the lowest level, inadvertently setting a low tone may result in an audible alarm that is more difficult to hear.
  • Action
    Hospira is providing work around instructions and will be updating the Instructions for Use (IFU).

Device

Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infus...
  • Model / Serial
    Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)Plum A+ Pump Version 11.6Catalogue number 611239101Number on pump: 12391/11971Plum A+ Pump Version 13.4 Med Net ABG DriverCatalogue number: 612079201Number on pump 20792ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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