Events

Prismaflex Control Units 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-2018-RN-00366-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00366-1
  • 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 will be installing new firmware on all prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. the failure mode may result in a “voltage out of range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. this failure mode can occur at any time during treatment or outside of treatment. to date, there have been no reports of serious injury associated with this issue.
  • 조치
    Baxter advises that a service representative will be in contact with customers to schedule the firmware upgrade to rectify this issue. Until the firmware has been installed, users may continue to use the units that have not exhibited the "Voltage Out of Range" malfunction alarm.

Device

Prismaflex Control Units
  • 모델명 / 제조번호(시리얼번호)
    Prismaflex Control Units Product Codes: 955052, 114870, 114489, 107493, 113082, 113874All serial numbers of the above product are affectedARTG Number: 142047(Baxter Healthcare - Prismaflex - Therapeutic plasma exchange system)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd