Events

GemStar infusion system 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Hospira 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2014/010
  • 사례 연번
    CON392878
  • 날짜
    2014-03-13
  • 사례 출판 날짜
    2014-03-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON392878?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of delay to patient therapy due to loss of audio alarms. the connection between the beeper subassembly and pump may fail so that only visual alarms will be available. the pump will only identify the beeper failure during ‘self-test’ whilst powering up, which will prevent it from being programmed or used. pumps that were previously fixed for this beeper failure may fail again.
  • 조치
    Use an alternative pump, where available. If an alternative is not available, assess the risks and benefits of using the pump for each patient. Be aware of the MHRA’s advice on GemStar infusers in MDA/2013/078. Report any adverse incidents involving these pumps to the MHRA. Action by: All medical, nursing and technical staff involved in the use of these pumps.

Device

GemStar infusion system
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    MHRA