Events

Injectomat Agilia Range (Std, MC & TIVA), Volumat Agilia Range (Std & MC) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Kabi Australia Pty Limited 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-2014-RN-00493-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00493-1
  • 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
    Frensenius kabi initiated a software upgrade due to three incident reports concerning three different issues:injectomat and volumat pumps:1. the pdms from picis implemented an unexpected high number of connection/disconection requests resulting in a "watchdog" error message.2. if the user configured the vigilant drug lib software with a drug with fixed dilutions, the selection on the pump of this drug as a first step then followed by the selection of 'drug x in ml/hr' as a second step could result in the display of a technical error. concerning injectomat pumps: 3. in a high vibration environment, for example close to the warming device, the syringe installation check sensor signal can be unstablepotentially triggering a technical error (n-deg 23).This action was undertaken prior to notifying the tga.
  • 조치
    Fresenius Kabi has updated the software of all affected Injectomat and Volumat devices.

Device

Injectomat Agilia Range (Std, MC & TIVA), Volumat Agilia Range (Std & MC)

Manufacturer

Fresenius Kabi Australia Pty Limited