Events

Safety Alert Or Field Safety Notices for Total intravenous anaesthesia sets (TIVA)

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 Global Components Medical Ltd.

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/2016/021
  • Date
    2016-10-27
  • Event Date Posted
    2016-10-27
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/total-intravenous-anaesthesia-sets-tiva-risk-of-leakage-during-use
  • 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
    Manufactured by global components medical ltd – if propofol leaks from the check valve luer lock connector patients could become aware during surgery (mda/2016/021).
  • Action
    The manufacturer is due to release updated instructions for use to include recommendations for handling the Luer lock connectors in the anaesthesia set.Whilst waiting for this advice, please ensure that you:identify whether you have stocks of any of the product codes listed below use alternative devices if possible.If no alternatives are available:contact the manufacturer to obtain advice on tightening the Luer connector in the anaesthesia set be vigilant over possible leakages, particularly after more than one use e.g. after multiple syringe changes.

Device

Total intravenous anaesthesia sets (TIVA)
  • Model / Serial
  • Product Description
    Product code Description GCM-1003 10 METRE TIVA MRI SET GCM-223 3 WAY TIVA SET 2.2 METRE GCM-223B 3 WAY MULTIPLE INFUSION TIVA SET 2.2 METRE BASIC GCM-253 3 WAY TIVA SET 2.5 METRE GCM-253B 3 WAY MULTIPLE INFUSION TIVA SET 2.5 METRE BASIC GCM-303B 3 WAY MULTIPLE INFUSION TIVA SET 3.0 METRE BASIC GCM-304 4 WAY TIVA SET 4.0 METRE GCM-SPCA SEDATION PCA SET 2.2 METRE
  • Manufacturer
    Global Components Medical Ltd

Manufacturer

Global Components Medical Ltd
  • Manufacturer Address
    Global Components Medical Ltd Tel: 01276 679394regulatory@global-medical.co.uk
  • Manufacturer Parent Company (2017)
    Global Components Medical Limited
  • Source
    MHRA