Events

enFlow® IV fluid and blood warmer 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Vyaire 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
  • 날짜
    2019-03-19
  • 사례 출판 날짜
    2019-03-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-updated-safety-advice-from-manufacturer-mda-2019-016
  • 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
    This MDA replaces MDA/2019/015.The manufacturer has provided MHRA with additional evidence that suggests using the enFlow system with lactated Ringer’s, platelets, plasma, whole blood, packed red blood cells and Sterofundin may lead to a risk of administering potentially harmful concentrations of aluminium.
    Following comprehensive and continuing investigation by MHRA, we recommend measures are put in place to source alternative fluid warming devices as soon as possible. If no alternative devices are available in the short term, overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release.
    MHRA continues to investigate whether other devices on the market also release higher than recommended levels of aluminium and will take action where necessary.
  • 원인
    Manufactured by vyaire – cartridges with an aluminium warming plate in the fluid pathway can lead to an iv infusion containing aluminium above currently recommended safe levels.
  • 조치
    Use an alternative fluid warming device if available. If alternatives are available, follow the instructions in the manufacturer’s updated Field Safety Notice. In the short term, if no alternative is available, carry out and document a local risk assessment based on a clinical risk-benefit analysis before using this fluid warmer. Overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release. Put measures in place to source alternative fluid warming systems. Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

enFlow® IV fluid and blood warmer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 제품 설명
    The intended use of the enFlow IV Fluid/Blood Warming System is for warming blood, blood products and intravenous solutions prior to administration. It is designed to be used by healthcare professionals in the hospital, clinical and field environments to help prevent hypothermia. The system consists of the enFlow heating system and the disposable cartridge.Description Manufacturers reference NHS Supply Chain reference Blood and fluid warming unit 980105VS FSB1143 Blood and fluid warming disposable cartridges 980200EU FSB1143 Blood and fluid warming disposable cartridges with extension (30) 980202EU FSB1143
  • Manufacturer
    Vyaire

Manufacturer

Vyaire
  • 제조사 주소
    Vyaire Medical 26125 North Riverwoods Blvd. Mettawa 60045 USATelephone +1 833 327 3284Email Bob.Arnott@vyaire.com
  • 제조사 모회사 (2017)
    Vyaire Holding Company
  • Source
    MHRA