Events

Prismaflex Control Unit (with software versions prior to 8.10) 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-2017-RN-00385-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00385-1
  • 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
    Baxter healthcare has received reports of device operators failing to adhere to the instructions for use (ifu) pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome.
  • 조치
    Baxter will be installing a free software upgrade at the users' facility. In the interim, Baxter is advising users that they may continue to use the affected units by following the instructions provided in the Prismaflex Operator’s Manual and the on-screen instructions when unloading the disposable set. Specifically, users should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading.

Device

Prismaflex Control Unit (with software versions prior to 8.10)
  • 모델명 / 제조번호(시리얼번호)
    Prismaflex Control Unit (with software versions prior to 8.10)Prismaflex 4.11Product Code: 113082Prismaflex 6.10 ROWProduct Code: 114489Prismaflex 7.XX ROWProduct Code: 114870All Serial NumbersARTG Number: 142047
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd