Events

Alaris System Syringe Module 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-01080-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01080-1
  • 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
    There has been a previous notification (tga ref.: rc-2015-rn-00767-1) for devices manufactured during a specific time period, however further root cause analysis has shown all manufactured syringe drivers/modules prior to july 2015 are affected. carefusion has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached pc unit (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses until the next power cycle, or the module is detached and re-attached. this error could occur during an infusion causing an interruption of infusion.
  • 조치
    CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016.

Device

Alaris System Syringe Module
  • 모델명 / 제조번호(시리얼번호)
    Alaris System Syringe Module Model Number: 8110Material Number:10930269Serial Numbers: ALL distributed Alaris System Syringe modules in Australia to dateARTG Number: 175353
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd