Events

GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps) 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-2014-RN-00152-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00152-1
  • 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 complaints, hospira has become aware that in the gemstar (phase 3) infusion pumps, the connection between the beeper subassembly and the pump may fail. the gemstar infusion pump will identify this failure during the “self-test” while powering up which will result in a beeper error. this beeper error will display on the device with a service error code “code 10/001/000”. this beeper error (service code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
  • 조치
    Customers are advised that there is no need to return their GemStar Phase 3 Infusion pumps at this time. If a Beeper Error occurs during power up, customers are asked to remove the device from service immediately and contact Hospira to arrange for a loan pump.

Device

GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)
  • 모델명 / 제조번호(시리얼번호)
    GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)List Numbers: 13000 and 13150ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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