Events

Spectra Optia Apheresis System with Software Version 11 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Terumo BCT 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-00963-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00963-1
  • 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
    A defect in optia version 11 sw can cause an unexpected behaviour to the rinseback option when the wbc or platelet counts are updated during the run and they are sufficiently different from the previous counts. the absence of rinseback could result in loss of rbc potentially resulting in limited illness or injury. unintended rinseback carried out on a very small patient could result in symptomatic hypervolemia. no serious injury or deaths have been associated with this behaviour.
  • 조치
    Terumo BCT is actively working on a software update to correct this behaviour. Once this software is available affected devices will be updated. End users are being provided work around instructions to ensure the continued safe use of the device. This action has been closed-out on 14/07/2016.

Device

Spectra Optia Apheresis System with Software Version 11
  • 모델명 / 제조번호(시리얼번호)
    Spectra Optia Apheresis System with Software Version 11 Catalogue Number: 61000ARTG Numbers: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd