Events

Heater Cooler Unit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Maquet Cardiopulmonary AG 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
    20582
  • 사례 시작날짜
    2016-08-30
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • 원인
    Maquet cardiopulmonary have received reports confirming the presence of mycobacterial contamination (and other bacterial contaminants) in the system water of heater and heater/cooler devices, mainly used during cardiothoracic surgeries to warm or cool a patient. although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device's exhaust vent into the environment and to the patient.
  • 조치
    Manufacturer to issue advice regarding use

Device

Heater Cooler Unit
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: HU 35, HCU 20, HCU 30 & HCU 40
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG