Events

Recall of GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)

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-2014-RN-00152-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00152-1
  • 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
    Through customer complaints, hospira has become aware that in the gemstar (phase 3) infusion pumps, the connection between the beeper subassembly and the pump may fail. the gemstar infusion pump will identify this failure during the “self-test” while powering up which will result in a beeper error. this beeper error will display on the device with a service error code “code 10/001/000”. this beeper error (service code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
  • Action
    Customers are advised that there is no need to return their GemStar Phase 3 Infusion pumps at this time. If a Beeper Error occurs during power up, customers are asked to remove the device from service immediately and contact Hospira to arrange for a loan pump.

Device

GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)
  • Model / Serial
    GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)List Numbers: 13000 and 13150ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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