Events

Alerte Ou Avis De Sécurité sur Total intravenous anaesthesia sets (TIVA)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Global Components Medical Ltd.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2016/021
  • Date
    2016-10-27
  • Date de publication de l'événement
    2016-10-27
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/total-intravenous-anaesthesia-sets-tiva-risk-of-leakage-during-use
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Adresse du fabricant
    Global Components Medical Ltd Tel: 01276 679394regulatory@global-medical.co.uk
  • Société-mère du fabricant (2017)
    Global Components Medical Limited
  • Source
    MHRA