Events

Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails 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/2013/062
  • 사례 연번
    CON300410
  • 날짜
    2013-08-08
  • 사례 출판 날짜
    2013-08-08
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON300410?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 to therapy. a fault with the front and rear bearings of the pump’s stepper motor may cause the pump to stall during an infusion. the pump stops, alarms and displays a ‘drv1’ or ‘drv2’ error on the screen. replacement of the motors will begin in september 2013. carefusion issued a field safety notice (fsn) in may 2013. the motor stall condition may occur during start-up (immediately after the start key is pressed) or during an infusion, which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.
  • 조치
    Identify affected pumps. Consider using an alternative pump, particularly if an interruption to an infusion could compromise patient safety. If an alternative pump is not available, follow the advice in the manufacturer’s instructions for use. In particular if a ‘DRV1 or DRV2’ error is displayed, immediately remove the pump from use and contact CareFusion. Return completed verification form in the FSN to CareFusion. When available, ensure the stepper motors are replaced.

Device

Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Specific serial numbers are affected. General purpose volumetric infusion pumps intended for acute and sub-acute applications. Product codes: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G. The serial numbers of affected pumps are specific to each customer. Contact your local biomedical engineering department to obtain this list or contact CareFusion directly to determine which pumps are affected. The serial number is printed on the back of each pump. The MHRA does not possess a list of affected serial numbers.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion