Events

Recall of All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infusion System

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-00248-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00248-1
  • 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
    A lithium battery, that is not user accessible, is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. if the battery’s voltage level drops below 2.4 volts, an 11/004 error will be displayed and the device will not be able to be used, resulting in a possible delay/interruption in therapy. additionally, the infusion settings and event history logs will be erased.
  • Action
    If the GemStar device displays an 11/004 error, users are advised to immediately remove it from clinical service and return it to Hospira for battery replacement. Lithium batteries that are older than five (5) years should be replaced. A preventative maintenance program is being developed to ensure the lithium batteries are changed out prior to the end of life. 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 delay/interruption in therapy or under/over infusion could result in significant injury or death.

Device

All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infus...
  • Model / Serial
    All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infusion SystemGemStar Infusion System - Single TherapyCatalogue Number: 611308801Number on Pump: 13088 / 13150GemStar 7 Therapy Infusion SystemCatalogue Number: 611308701Number on Pump: 13087 / 13000
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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