MiniCap peritoneal dialysis disconnect cap with povidone-iodine 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Baxter Healthcare Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2006/022
  • 날짜
    2006-03-22
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    (baxter healthcare ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (mda/2006/022).
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine.
  • Manufacturer

Manufacturer

  • 제조사 주소
    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
  • 제조사 모회사 (2017)
  • Source
    MHRA