Events

Safety Alert Or Field Safety Notices for GemStar infusion system

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/2014/010
  • Event Number
    CON392878
  • Date
    2014-03-13
  • Event Date Posted
    2014-03-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON392878?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
    Risk of delay to patient therapy due to loss of audio alarms. the connection between the beeper subassembly and pump may fail so that only visual alarms will be available. the pump will only identify the beeper failure during ‘self-test’ whilst powering up, which will prevent it from being programmed or used. pumps that were previously fixed for this beeper failure may fail again.
  • Action
    Use an alternative pump, where available. If an alternative is not available, assess the risks and benefits of using the pump for each patient. Be aware of the MHRA’s advice on GemStar infusers in MDA/2013/078. Report any adverse incidents involving these pumps to the MHRA. Action by: All medical, nursing and technical staff involved in the use of these pumps.

Device

GemStar infusion system
  • Model / Serial
  • Product Description
    Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.
  • Manufacturer
    Hospira

Manufacturer

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