Events

Recall of Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)

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-01251-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01251-1
  • 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
    1. when the docking station is used in conjunction with a gemstar phase 3 pump (list 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station.2. the second situation arises when either a gemstar phase 3 (list 13000-xx, 13100-xx or 13150-xx) or gemstar phase 4 pump (list 13086-xx, 13087-xx or 13088-x) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx). with this configuration, there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • Action
    Hospira is providing work around instructions to mitigate the issues. if the device fails to power up end users are advised to remove the pump from the Docking Station and then power on the pump using 2 fresh AA batteries. To mitigate the 11/003 Error Code, end users must remove the battery pack prior to installing the pump on the docking station. If users are using a docking station in conjunction with an external battery pack accessory (List 13073), Hospira is advising that this practice should not continue. Users are advised to contact Hospira to discuss an appropriate alternative option.

Device

Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to ...
  • Model / Serial
    Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)List Number: 13075-XX-07 and 13075-XX-09ARTG Number: 138118
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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