Events

Gemstar Infusion System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira 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-2013-RN-01218-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01218-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    Through customer reports, hospira has become aware that patients or unauthorised carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with the programmed infusion parameters. hospira have received no reports relating to this issue in australia. one of the reports overseas resulted in a serious injury.
  • 조치
    Hospira is recommending users change the default keypad lock code upon receipt of the device and prior to delivery to patients, and remove the clinical instructions from the manual to prevent unauthorised access. Hospira will be providing users with an updated System Operating Manual to include the requirement to change the default keypad code.

Device

Gemstar Infusion System

Manufacturer

Hospira Pty Limited
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA