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 Number
    MDA/2013/016
  • Date
    2013-03-26
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-gemstar-infusion-system-risk-of-over-infusion-low-infusion-rates-or-an-interruption-of-infusion
  • 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
    The following pump faults may lead to over-infusion, low infusion rates or an interruption of infusion:occlusion detection problems, due to pressure sensor calibration drift;
    pump failure without warning, due to leaking batteries;
    voltage of lithium battery dropping below 2.4 volts, causing pump to cease functioning;
    an error with the pump’s motor assembly potentially causing the motor to rotate backwards at flow rates of less than 2 ml/hr.The MHRA continues to investigate this and other recent Field Safety Corrective Actions implemented by Hospira.
  • Reason
    (hospira) due to pump faults. (mda/2013/016).
  • Action
    Identify affected pumpsDo not use these pumps on neonates and infants aged 2 years and under.Do not use flow rates of less than 2 ml/hour.Consider using an alternative device, particularly if an an over/under infusion, or an interruption to an infusion could compromise patient safety.If an alternative is not available, follow the advice in each of the manufacturer’s Field Safety Notices.

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