Events

Homechoice Pro APD System (peritoneal dialyser) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2013-RN-01117-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01117-1
  • 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
    An occluder blade clamps the solution lines if a power failure occurs or when the cycler is off preventing uncontrolled solution delivery to the patient. the occluder may contain sharp edges and/or separate from the back plate, which may cause the occluder assembly to fail resulting in an unrecoverable slowflow/no flow alarm/system error.
  • 조치
    Baxter is informing the affected hospitals of the issue. Affected devices are to be returned and replaced with unaffected devices. Baxter is advising patients if there is an unrecoverable failure to perform manual peritoneal dialysis to continue therapy.

Device

Homechoice Pro APD System (peritoneal dialyser)
  • 모델명 / 제조번호(시리얼번호)
    Homechoice Pro APD System (peritoneal dialyser)Product Code: R5C8320Serial Number: 300905, 300882, 300928, 300889ARTG Number: 172780
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd