Events

Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, Oasis 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Atrium Australia - Pacific Rim Pty Limited 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-01159-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01159-1
  • 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
    Atrium medical has become aware that the force required to detach the tubing from the drain may be lower than atrium medical's product specifications. the manufacturer has received reports for leaking of blood or disconnection of the drain at the connection point of the ats access line and the chest drain. the leaks or disconnection occurred following usage of the drain in excess of 2 days and typically were related to movement of the patient within the institution.
  • 조치
    Atrium Medical is advising their customers to quarantine affected products and use an appropriate substitute device. If an adequate substitute is not available customers are advised to review the substitution list and contact Atrium for assistance in obtaining the substitute device. It is further advised that in the event of an emergency situation the affected devices can continue to be used provided work around instructions are followed.

Device

Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of ...
  • 모델명 / 제조번호(시리얼번호)
    Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, OasisProduct Codes: 2050-300, 3650-100Lot/Serial Numbers: 10883118, 10891209, 10899344, 10883101, 10891238, 10906323ARTG Number: 126675
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA