Events

Advanced Perfusion System 1 (heart-lung bypass machine) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Terumo 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-2012-RN-01216-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-11-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01216-1
  • 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 manufacturer has received five reports between 2003 and 2012 of spontaneous power loss to the terumo system 1. in all reports the systems lost full power and did not switch to battery backup without warning. in one report the system re-booted automatically after about 30 seconds and in the remaining reports the system regained power after toggling the main power switch. in all of the reports the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.
  • 조치
    An update to the instructions for use (IFU) is being issued to customers as an interim measure and the manufacturer's investigation into the root cause investigation is ongoing. Terumo is advising that should the investigation conclude that a corrective action is necessary, users will be notified.

Device

Advanced Perfusion System 1 (heart-lung bypass machine)
  • 모델명 / 제조번호(시리얼번호)
    Advanced Perfusion System 1 (heart-lung bypass machine)Product Code: 801764Batch Numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027 & 1100-1429ARTG Number: 93976
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd