Events

Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cellplex 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-00961-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-09-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00961-1
  • 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
    There have been reports received of a "fault in motor controller" alarm message. if this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
  • 조치
    Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required

Device

Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung ...
  • 모델명 / 제조번호(시리얼번호)
    Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)S5 Single Roller Pump 150Product Code: 10-80-00Serial Number: 10E06300, 10E06301 and 10E06302S5 Double Roller Pump 85Product Code:10-85-00Serial Number: 10E51883ARTG Number: 108387
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd