Events

Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution Dual Hemo MCable Pods with Revision Index RI15 and RI16 Manufactured between August 2015 to August 2016 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger 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-01269-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01269-1
  • 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
    Dräger has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. dräger has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15 and after ri17 continue to meet the ipx4 standard.
  • 조치
    Dräger are advising users to inspect systems to identify any affected products. Dräger will be providing customers with a sleeve to apply in order to prevent the issue from occurring.

Device

Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution...
  • 모델명 / 제조번호(시리얼번호)
    Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring SolutionDual Hemo MCable Pods with Revision Index RI15 and RI16Manufactured between August 2015 to August 2016ARTG Number: 138056
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd