Events

Sorin 1T /3T FlexTherm Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Sorin Group Deutschland GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20357
  • 사례 시작날짜
    2016-07-08
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 원인
    The instructions for use for the 1t and 3t/flextherm system prescribe the addition of 50ml and 150ml respectively of medical grade 3% hydrogen peroxide to the filtered tap water in the device, which results in a maximum concentration of approximately 330ppm. the purpose of adding the hydrogen peroxide is to prevent microbial growth between the regular cleaning / disinfection cycles performed every 2 weeks., the manufacturer has determined that plastic heat-exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow for diffusion of some quantity of hydrogen peroxide during a typical procedure.
  • 조치
    Manufacturer to issue advice regarding use

Device

Sorin 1T /3T FlexTherm Systems
  • 모델명 / 제조번호(시리얼번호)
    Model: 16-02-50 16-02-80 16-02-91 16-02-82 16-02-83 16-02-85 16-02-95 and 16-70-00, Affected:
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH