Events

Alaris System PC Unit model 8015 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-2015-RN-00289-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00289-1
  • 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
    Carefusion usa (the manufacturer) has identified an issue with the pc unit model 8015 following receipt of reports from customers experiencing a system error. a system error (code 110.6021) is displayed with concurrent audio and visual alarm, however it cannot be cleared by restarting or rebooting the pc unit. the error code may occur upon power on during the “power-on self test” due to a keypad issue. the power-on self test is designed to occur during power on, in order to detect issues prior to initiation of an infusion. the system cannot be cleared by restarting or rebooting the pc unit.
  • 조치
    CareFusion will replace the affected front keypad assembly on the Alaris PC unit. In the interim end users have been provided with work around instructions to minimise risk to patients. This action has been closed-out on 12/08/2016.

Device

Alaris System PC Unit model 8015
  • 모델명 / 제조번호(시리얼번호)
    Alaris System PC Unit model 8015Material Codes: 8015LSBIXEN9121; 8015LSAIXE9121; 8015LSCIXE91240; 12279909Manufactured between September 1, 2012 and October 22, 2013 having a 5.7” screenARTG Number: 146666
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd