Alerte Ou Avis De Sécurité sur MiniCap peritoneal dialysis disconnect cap with povidone-iodine

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 Baxter Healthcare 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/2006/022
  • Date
    2006-03-22
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • 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
    The povidone-iodine contained in the disconnect caps of these peritoneal dialysis sets has the potential to be a contributing factor to thyroid changes such as hypothyroidism. Patients more likely to be affected are infants and children with smaller peritoneal fill volumes, where higher dialysate concentrations of iodine can result.
  • Cause
    (baxter healthcare ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (mda/2006/022).
  • Action
    The thyroid function should be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. In order to minimise iodine exposure, the contents of the peritoneal cavity should be drained to the drain receptacle prior to the initiation of the next fill cycle whenever clinically possible.Users should be aware of the advice in Baxter’s Safety Alert (see appendix in pdf).

Device

  • Modèle / numéro de série
  • Description du dispositif
    Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Enquiries to the manufacturer should be addressed to:Surecall-Baxter Medical Information, Baxter Healthcare Ltd, Wallingford Road, Compton, Newbury, Berkshire RG20 7QWTel: 01635 206 345Fax: 01635 206 071E-mail: surecall@baxter.com
  • Société-mère du fabricant (2017)
  • Source
    MHRA