HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MAQUET-DYNAMED INC. 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
    125724
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-06-28
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    In very rare cases it is possible for a hl 20 twin pump module (tpm) to unintentionally increase its speed for a 1.5 - 2 second period of time before returning to its originally set speed. this malfunction can only occur when the tpm is used for cardioplegia and set up in a master/ slave configuration. during the malfunction a very transient incorrect mixing of the cardioplegia solution can occur before the pump speed returns to its original setting. this behavior can only occur when one of the tpm pumps is set as cardioplegia slave and the as cardioplegia master pump. when the tmp is used in any other confirguation this malfunction does not occur.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: TPM 20-330 (Lot serial: > 10 numbers contact mfg)
  • 제품 설명
    HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC