Events

Perfusor Space infusion 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 B Braun 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/2013/080
  • 사례 연번
    CON341212
  • 사례 출판 날짜
    2013-11-21
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON341212?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 interruption of therapy when changing syringe. if an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator on the pump showing a full charge. this could lead to the therapy unexpectedly stopping. the problem does not arise if the pump is plugged into the mains electrical supply. please see the manufacturer’s field safety notices (technical or clinical).
  • 조치
    Ensure all relevant staff are aware of the problem and of the guidance in the Field Safety Notice. Identify and replace or test any batteries that are 4 years or older as detailed in the service manual. During transportation of patients: Do not use a pump with aged batteries, if possible. In all cases make sure a spare battery or pump is available, as detailed in the user manual. Actions by All those responsible for the use or maintenance of the devices.

Device

Perfusor Space infusion pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Perfusor Space infusion pump. The service manual , page 6-3, provides guidance on the identification of pumps with affected batteries.
  • Manufacturer
    B Braun

Manufacturer

B Braun