Events

All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps 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/BD Medical 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
  • 날짜
    2017-04-12
  • 사례 출판 날짜
    2017-04-12
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/all-alaris-gs-gh-cc-tiva-pk-enteral-syringe-pumps-and-asena-gs-gh-cc-tiva-pk-syringe-pumps-risk-of-uncontrolled-bolus-of-medicine
  • 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
    Manufactured by carefusion/bd medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps.
  • 조치
    Identify all devices with the product codes listed in the FSN Ensure hospital or Carefusion service specialist checks pumps as detailed in the FSN Prioritise devices used in paediatric/neonatal/critical care areas and all devices more than three years old Ensure hospital or CareFusion replace broken springs Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s updated preventative maintenance Note that this alert replaces MDA/2017/003, which we published in February 2017

Device

All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syring...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Product Name: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005, 8007Product Name: Asena™ GS, GH, CC, TIVA, PK Syringe Pumps Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005
  • Manufacturer
    CareFusion/BD Medical

Manufacturer

CareFusion/BD Medical
  • 제조사 주소
    CareFusionTel: 0800 917 8776Email: UK-customer-service@carefusion.com
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    MHRA