Events

Alaris® GP volumetric pump 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 CareFusion 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/2013/017
  • 사례 연번
    CON254808
  • 날짜
    2013-03-26
  • 사례 출판 날짜
    2013-03-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON254808?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 embolism. the pump produces small air bubbles (less than 50μl) which are too small to trigger either the 50-500μl air-in-line alarm set by the user, or the 1ml over a rolling 15 minutes alarm.
  • 조치
    Identify affected devices. Ensure members of staff are aware of the advice detailed in the manufacturer’s Field Safety Notice. In particular, CareFusion recommends the use of an air venting filter on the infusion set for the following patient groups: patients with atrial septal defects* neonates where multiple infusions are being administered simultaneously. Where a filter cannot be used, consider using an anti-siphon valve on the infusion set. Be aware of additional advice issued by CareFusion – see appendix. * up to 20% of the population may have patent foramen ovale, which may be undetected.

Device

Alaris® GP volumetric pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Infusion pump: Alaris® GP volumetric pump Product refs: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G All serial numbers are affected.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion