Events

AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AA-Med 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-2015-RN-00118-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00118-1
  • 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
    Edwards lifesciences (previous legal manufacturer of aquarius devices in the market) initiated a fsca to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. field safety notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.Nikkiso europe (manufacturer of aquarius devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing total fluid loss (tfl) management in software 6.02. this product improvement is accompanied by a revised instructions for use (ifu).
  • 조치
    Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.

Device

AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device
  • 모델명 / 제조번호(시리얼번호)
    AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration DeviceProduct Codes: GEF09500, All Citrate Platform 6 Devices ARTG Number:189947
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA