Events

GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack) 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-2012-RN-00708-3
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-07-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00708-3
  • 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
    This is an update to hospira’s previous safety alert notice (tga ref # rc-2011-rn-00812-3) concerning the gemstar docking station. at that time, hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the gemstar docking station. hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. the design improvements have now been finalised and hospira is replacing all existing docking stations with the new design.
  • 조치
    Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units.

Device

GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a G...
  • 모델명 / 제조번호(시리얼번호)
    GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)List Numbers: 13075.1 and 13075.3 (2003 - 2006); 13075-24-03, 13075-24-05 & 13075-24-07 (2006 - 2011)ARTG Number: 138118
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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