Events

Protect-A-Line extension set 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Vygon 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/2013/056
  • 사례 연번
    CON297509
  • 날짜
    2013-07-25
  • 사례 출판 날짜
    2013-07-25
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297509?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 false occlusion alarms and interruption to therapy. this is due to a new anti-syphon valve supplied with the sets, which has a higher opening pressure and may require adjustment of infusion pump occlusion alarm settings to avoid false occlusion alarms. vygon are validating a further modification to the anti-syphon valves to marginally reduce the required opening pressure and will supply sets incorporating these once verification has been completed.
  • 조치
    Ensure that all members of staff are made aware of the recommended actions in the manufacturer’s Field Safety Notice. As some hospitals may be using both types of anti-syphon valve, be vigilant if you alter your infusion pump occlusion alarm settings for the new valves.  Make sure you do not have the previous design of valve (which operates at a lower opening pressure) on the line. The product codes for these previous devices are: 0832.01R, 0832.04R and 0832.211R.

Device

Protect-A-Line extension set
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Protect-A-Line extension set. Product codes: 0832.01, 0832.04 and 0832.211. NHS Supply Chain codes (England only): FSB128, FSB124 and FSB0146.
  • Manufacturer
    Vygon

Manufacturer

Vygon