Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Hospira Inc 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 101 03 12 000
  • 사례 시작날짜
    2012-03-25
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1619
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Hospira, inc. has received customer reports of bolus delivery failures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the bolus cord. potential risk due to failure of the bolus cord is the potential for an unrequested bolus delivery or the failure to deliver requested medication to the patient. the amount of unrequested delivery will be limited by programming lockout volumes. an unrequested narcotic delivery may cause over sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. the failure to deliver requested narcotic medication may result in the lack of adequate pain relief.

Device

Infusion pump, GemStar Bolus Cord
  • 모델명 / 제조번호(시리얼번호)
    List Number 13027 Serial no.: All Lot/batch no.: All
  • 제품 설명
    Infusion pump, Bolus Cord, delivery
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • 제조사 모회사 (2017)
    Pfizer
  • 제조사 대표
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA