Events

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2013-RN-00889-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00889-1
  • 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
    An omission has been identified in chapter 4 (operating instructions - secondary infusions) of the current revision of the operator's manual for the colleague product codes 2m91617 and 2m91637. the operator's manual should also instruct the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.
  • 조치
    Baxter is providing additional information to be included in the Operator's Manual instructing users to reopen the regulating clamp after a secondary infusion has completed. Customers are requested to ensure that this information is communicated to all appropriate clinical staff and to retain the letter with the Operator's Manual. This action has been closed-out on 12/04/2016.

Device

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)
  • 모델명 / 제조번호(시리얼번호)
    Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)Colleague P1.7 CXE Single Channel PumpProduct Code: 2M91617Colleague P1.7 CXE Triple Channel PumpProduct Code: 2M91637ARTG Number: 177497
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd