Events

Organ Care System (OCS) Heart system - OCS Heart Console 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Transmedics 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-2017-RN-00724-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00724-1
  • 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 identified a potential issue with the ocs heart device that could affect proper operation. in particular, the blood warmer may heat beyond the set limit if the heart perfusion module (hpm) is not installed in the ocs console prior to taking the system out of standby mode. use of the ocs heart device to support an organ at an elevated temperature may result in organ damage and/or turndown of organ for transplantation.
  • 조치
    TransMedics will be correcting this issue through an update to the software and Instructions For Use (IFU). In the interim, users are to follow the directions in the Product Information Bulletin provided with the customer letter. The Bulletin describes the recommended sequence for installing the HPM into the OSC Console. In order to ensure proper performance, such as maintaining the configured blood temperature, users are to include the HPM in the system’s Self-Test by installing the HPM in the OCS Heart Console while the system is in Standby Mode.

Device

Organ Care System (OCS) Heart system - OCS Heart Console
  • 모델명 / 제조번호(시리얼번호)
    Organ Care System (OCS) Heart system - OCS Heart ConsoleOSC Heart Console Reference Number: 1200Serial Numbers: 2486-1-15132, 2486-1-15129, 4929-4-15182ARTG Number: 146269
  • Manufacturer
    Transmedics Pty Ltd

Manufacturer

Transmedics Pty Ltd
  • Source
    DHTGA