Events

FMS Intermediary Tubing with One-Way Valve (used with FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-00949-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00949-1
  • 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
    Internal testing has identified that the one-way check valve (pillow valve) included in the fms outflow tubing set and the fms intermediary tubing set may occasionally not be performing as intended. if the instructions described in the fms duo system and solo system operator's manuals are not followed, this may result in backflow of irrigation fluid into the "one day" set, and when used with affected tubing, could potentially lead to patient cross-contamination. please note that the backflow of irrigation fluid can only occur if the check valve is not working properly and the pressure line is disconnected or the tension rocker is open.
  • 조치
    Customers are asked to quarantine any affected stock and return it to JJM. Customers are also advised that when connected properly and used in accordance with the system’s Operating Manual, tubing with an affected check valve will not allow backflow of irrigation fluid into the One Day Set, and would not lead to potential patient cross-contamination. It is important to follow up with potentially affected patients per each institution’s Infectious Disease/Needle stick protocol.

Device

FMS Intermediary Tubing with One-Way Valve (used with FMS Fluid Management Systems in a surgical ...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia