Events

multiFiltratePRO devices (Haemodialysis system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Medical Care 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-00324-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00324-1
  • 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
    Customer reports regarding the inadvertent opening of the blood leak detector (bld) doors prior to commencement of treatment have been received by the manufacturer. further investigations have revealed that it is not possible to rule out the risk of the inadvertent door opening, including during treatment.An open bld door allows the filtrate tube to slip out. however, a device error message only appears if this happens prior to the filtrate tube being filled during preparation. if the tube moves out of the bld during treatment and this is not noticed, the device may not detect a blood leak in the filter. the bld door is more likely to open inadvertently if tubes are inserted incorrectly (e.G., incorrect segment of the filtrate tubing system).
  • 조치
    Fresenius Medical Care (FMC) is advising users to route the tube in accordance with the requirements in the Instructions for Use (IFU) and on the screen. Users are further advised to conduct regular checks to ensure that the catch mechanism of the BLD door is operating fully and correctly especially, in particular, if the tubing system has been moved. Customers will be contacted by FMC regarding a free refitting solution in May 2017.

Device

multiFiltratePRO devices (Haemodialysis system)

Manufacturer

Fresenius Medical Care Australia Pty Ltd