Events

SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2017-RN-01528-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01528-1
  • 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
    Syncardia has updated the freedom driver system manuals and labelling to strengthen existing labelling content with regard to freedom driver drops, rough handling and exposure to liquid/debris. the freedom driver system manuals have been updated as follows: - advising patients to switch from their primary freedom driver to their backup freedom driver in the event their freedom driver is dropped, subjected to rough handling or exposed to liquid/debris. - adding more detailed information regarding the definition of rough handling. - advising hospital clinicians, patients and their caregivers to clean the freedom driver and drivelines only with a cloth lightly dampened with water. - advising hospital clinicians to refresh patient and caregiver training at every clinic visit.
  • 조치
    Device Technologies is providing users with updated manuals.

Device

SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart Sy...
  • 모델명 / 제조번호(시리얼번호)
    SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd