Events

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 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
    Field Safety Notice
  • 사례 연번
    SN2013(03)
  • 날짜
    2013-03-27
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/all-hospira-gemstar-family-of-infusers&id=087cf825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
    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
    Hospira has circulated six (6) field safety notices (fsns), since august 2011, advising of various issues relating to the gemstar family of infusers which could result in overdose, under-dose or a delay/interruption in therapy.
  • 조치
    1. Ensure that the appropriate personnel are made aware of this notice and the attached Caution in Use FSN.  2. Identify affected pumps.  3. Hospira has implemented the following Restriction for Use into clinical practice for the GemStar Infusion Pumps:  - Do not use on all neonatal populations and infants up to two (2) years of age.  - Do not use on any patients where therapy is delivered at flow rates 2.0ml/hr or less.  4. The manufacturer and the IMB advise users to weigh the risk/benefit to patients associated with the use of these devices when administering critical therapies.  5. Customers should consider the use of an alternative pump, particularly in patients in which an overdose, under-dose or delay/interruption in therapy could compromise patient safety.  6. Follow the manufacturer’s recommendations in the attached Caution in Use FSN.

Device

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    HPRA