Events

BBraun Perfusor Space Infusion Pump 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 B. Braun Melsungen AG 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
    SN2014(17)
  • 날짜
    2014-04-08
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bbraun-perfusor-space-infusion-pump.-priority-2---warning&id=85cff925-9782-6eee-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."
  • 데이터 추가 비고
  • 원인
    The irish medicines board (imb) wishes to remind users of a field safety notice (fsn) issued by b. braun in december 2013. b. braun has identified a risk that when the perfusor space pump is used with an aged battery, that the pump may not have sufficient current to perform a syringe change, despite the battery indicator on the pump showing full charge.  the issue can only occur when the pump is not connected to the mains and presents a risk when the pump is used on battery only.
  • 조치
    The IMB would like to remind users to:  (1) Follow the instructions outlined by the manufacturer in the FSN attached.  (2) Identify any batteries (or battery packs) of four years or older.  (3) Contact your Biomedical Engineering Department to arrange for replacement or testing of the battery (battery pack), as outlined in the device service manual.  (4) Always have an additional pump available for infusion of critical medications and during transport of patients.  (5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information.

Device

BBraun Perfusor Space Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG