Events

MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet Australia Pty Ltd 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
    RC-2013-RN-00104-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00104-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Maquet has identified two potential issues with the hl30 device which will be addressed in a software upgrade. first, in rare instances, as a result of an accidental impact or bump to the pump head cover, the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact, the unit may stop without an informational message explaining the reason for the stoppage. secondly, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause.
  • 조치
    Maquet is advising that if the unit stops, it can be reset by turning the potentiometer to zero. If the software anomaly with the cardioplegia module was to occur, the patient can be cross-clamped until the unit restarts, or transferred to another device. A Maquet Australia representative will be in contact with relevant staff at affected facilities to schedule the implementation of the corrective action.

Device

MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
  • 모델명 / 제조번호(시리얼번호)
    MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)All devices affectedARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd