Events

ADVANCED PERFUSION SYSTEM 1 - MODULES 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 TERUMO CARDIOVASCULAR SYSTEMS CORP. 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
    153878
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-08-10
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Terumo cardiovascular systems (terumo cvs) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500. some reports stated that the odor of smoke was associated with the failures. the malfunctions occurred during set-up during cardiopulmonary bypass and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed.

Device

ADVANCED PERFUSION SYSTEM 1 - MODULES
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 803479 (Lot serial: 00366-00498 (802113)); Model Catalog: 802113 (Lot serial: 00366-00498 (802113)); Model Catalog: 803518 (Lot serial: 00216-00283 (802113)); Model Catalog: 803479 (Lot serial: 00216-00283 (802113)); Model Catalog: 802113 (Lot serial: 00216-00283 (802113)); Model Catalog: 803518 (Lot serial: 00123-00214 (802113)); Model Catalog: 803479 (Lot serial: 00123-00214 (802113)); Model Catalog: 802113 (Lot serial: 00123-00214 (802113)); Model Catalog: 803518 (Lot serial: 00080-00121 (802113)); Model Catalog: 803479 (Lot serial: 00080-00121 (802113)); Model Catalog: 802113 (Lot serial: 00080-00121 (802113)); Model Catalog: 803518 (Lot serial: 00066-00077 (802113)); Model Catalog: 803479 (Lot serial: 00066-00077 (802113)); Model Catalog: 802113 (Lot serial: 00066-00077 (802113)); Model Catalog: 803518 (Lot serial: 00047-00064 (802113)); Model Catalog: 803479 (Lot serial: 00047-00064 (802113)); Model Catalog: 802113 (Lot serial: 00047-00064 (802113)); Model Catalog: 803518 (Lot serial: 00
  • 제품 설명
    SERIAL INTERFACE MODULE RS-232 INTERFACE MODULE FOR CDI SYSTEM 500 SERIAL INTERFACE MODULE RS-485
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • 제조사 주소
    ANN ARBOR
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    HC