Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Gambro 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-2014-RN-00860-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-08-05
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Gambro pty ltd is advising users of the potential for external fluid leakage from the ultrafilter u9000 due to multiple disinfections using a sodium carbonate-based solution. intensive use of sodium carbonate based disinfection programs over several months may cause degradation of the ultrafilter housing leading to an external fluid leakage at the position of the welding seal between the filter housing and the header cap. if the leakage is slow developing, there is a remote probability that it will not be noticed until the dialysis treatment has started.
  • 조치
    If a leakage is observed during treatment, the users are advised to immediately stop the treatment and change the U9000 Ultrafilter to avoid excessive fluid removal from the patient. Gambro is advising that the use of sodium carbonate-based disinfection programs has been broadly validated for the U9000 Ultrafilter. However, to minimise the risk of an external fluid leak, Gambro recommends adhering to the following instructions, when using sodium carbonate based disinfection programs: 1. Do not exceed the recommended disinfectant concentration given in the Operator’s Manual. 2. Do not use more than eight sodium carbonate disinfection cycles over the lifetime of the U9000. 3. Do not use sodium carbonate disinfection cycles more than once a week. 4. Include daily disinfection with citric acid in the disinfection protocol. 5. Avoid periods of machine inactivity (e.g. weekend storage) directly after disinfection with sodium carbonate based agents. 6. The recommended process of combined “Heat + CleanCart-A” disinfection shall be followed by a “Heat + CleanCart-C” disinfection on the same day and ideally be performed in the middle of the working week. This action has been closed-out on 03/06/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)ARTG Number: 131741
  • Manufacturer

Manufacturer