Events

Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP) 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-2014-RN-00365-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00365-1
  • 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
    The fan assembly for specific system 98/98xt, cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan assembly, causing the fan to stop rotating, which causes the power supply to overheat and the iabp to shut down without any visual or audible warning. patients receiving iabp therapy are in critical condition and a sudden interruption of therapy could result in unsafe haemodynamic instability.
  • 조치
    Clinicians are instructed to not leave the patient unattended during IABP therapy. Maquet is reminding users of the current warning in the IABP operating instructions ie, the patient balloon should not remain inactive in the patient (i.e., no inflating or deflating) for more than 30 minutes, due to the potential for thrombus formation. In the unlikely event that this situation was to occur, transfer the patient to an alternative Datascope IABP. If an alternative Datascope IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. A Maquet Service Representative will contact hospitals to schedule the replacement of the fan assembly.

Device

Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

Manufacturer

Maquet Australia Pty Ltd