Events

Safety Alert Or Field Safety Notices for Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails

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 CareFusion.

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/2013/062
  • Event Number
    CON300410
  • Date
    2013-08-08
  • Event Date Posted
    2013-08-08
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON300410?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 interruption to therapy. a fault with the front and rear bearings of the pump’s stepper motor may cause the pump to stall during an infusion. the pump stops, alarms and displays a ‘drv1’ or ‘drv2’ error on the screen. replacement of the motors will begin in september 2013. carefusion issued a field safety notice (fsn) in may 2013. the motor stall condition may occur during start-up (immediately after the start key is pressed) or during an infusion, which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.
  • Action
    Identify affected pumps. Consider using an alternative pump, particularly if an interruption to an infusion could compromise patient safety. If an alternative pump is not available, follow the advice in the manufacturer’s instructions for use. In particular if a ‘DRV1 or DRV2’ error is displayed, immediately remove the pump from use and contact CareFusion. Return completed verification form in the FSN to CareFusion. When available, ensure the stepper motors are replaced.

Device

Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails
  • Model / Serial
  • Product Description
    Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Specific serial numbers are affected. General purpose volumetric infusion pumps intended for acute and sub-acute applications. Product codes: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G. The serial numbers of affected pumps are specific to each customer. Contact your local biomedical engineering department to obtain this list or contact CareFusion directly to determine which pumps are affected. The serial number is printed on the back of each pump. The MHRA does not possess a list of affected serial numbers.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion