Events

Safety Alert Or Field Safety Notices for GemStar docking station for use with specific GemStar infusion pumps

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Hospira.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/085
  • Event Number
    CON355511
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON355511?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Potential for a delay in infusion therapy. two problems exist: when the docking station is used in conjunction with a gemstar phase 3 infusion pump, the pump may fail to power up when the gemstar phase 4 infusion pump is used in conjunction with both a docking station and an external battery accessory, this configuration could generate an error code 11/003, which could stop a running infusion. the manufacturer issued a field safety notice (fsn) dated 24 october 2013 but has not received sufficient confirmation that it has been received and acted upon.
  • Action
    Identify affected devices/device combinations. Use an alternative pump, where available. Be aware of the recommendations in MDA/2013/078. If an alternative is not available: assess the risks and benefits of using these pumps for each individual patient ensure that staff are aware of all the issues and actions to be taken as specified in the manufacturer’s Field Safety Notice exercise caution in use report any adverse incidents involving these devices to the MHRA. fill in and return the reply form to Hospira.

Device

GemStar docking station for use with specific GemStar infusion pumps
  • Model / Serial
  • Product Description
    GemStar docking station for use with specific GemStar infusion pumps. The specific products potentially affected by the two problems are shown below: Affected product (docking station list numbers) Issue Potential to occur in conjunction with products 13075-XX-07 13075-XX-09 Pump fails to power up Gemstar phase 3 pump (13000-XX, 13100-XX, 13150-XX) Error code 11/003 on pump and infusion stops Gemstar phase 4 pump (13086-XX, 13087-XX, 13088-XX) External battery pack (13073-XX) If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification. There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert MDA/2013/078 .
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA