Events

Aquarius GEF08200 Device, V4 Software 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-00626-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00626-1
  • 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
    Baxter is recalling this device due to the ability to override the total fluid balance alarm which could potentially lead to hypovolaemia or hypervolaemia. a software update was initially proposed to correct the issue for models gef08200 and gef09600, however as the software update was found to incompatible with model gef08200, baxter determined that there was no permanent solution available for this model.
  • 조치
    Hospitals are requested to provide Baxter with details of the units remaining in use. On receipt of this notification Baxter will organise for the recovery of the device. The Aquarius GEF08200 with V4 software can continue to be used until replacement devices are sourced provided the work around identified in the device Warning Label is followed. The warning label contains the following information: WARNING Repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. Beware this can cause serious patient injury. You need to identify the cause of the alarm and correct the fluid rate if necessary.

Device

Aquarius GEF08200 Device, V4 Software

Manufacturer

Baxter Healthcare Pty Ltd