Events

AlarisTM Syringe Pump – (CC, GH, GS, PK and TIVA) 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 CareFusion International 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 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Carefusion has identified that the alaris syringe pump & the nipro syringe are no longer compatible and nipro be removed from the list of recognised syringes. .

Device

AlarisTM Syringe Pump – (CC, GH, GS, PK and TIVA)
  • 모델명 / 제조번호(시리얼번호)
    AlarisTM CC, Universal 80033UNN0 AlarisTM CC, Universal, RS232 80033UNN1 AlarisTM CC, Universal, Dedicated 80033UND0 AlarisTM CC, Universal, Dedicated, RS232 80033UND1 AlarisTM CC Syringe Pump with Plus Software 8003MED01 AlarisTM CC with GuardrailsTM Safety Software, Universal, Dedicated 80033UND0-G AlarisTM CC with GuardrailsTM Safety Software, Universal, Dedicated, RS232 80033UND1-G AlarisTM CC Guardrails Syringe Pump with Plus Software 8003MED01-G AlarisTM CC Syringe Pump with Plus Software 8003TIG01 AlarisTM CC Guardrails Syringe Pump with Plus Software 8003TIG01-G AlarisTM GH, Universal 80023UN00 AlarisTM GH, Universal, RS232 80023UN01 AlarisTM GH Syringe Pump with Plus Software 8002MED01 AlarisTM GH with GuardrailsTM Safety Software, Universal 80023UN00-G AlarisTM GH with GuardrailsTM Safety Software, Universal, RS232 80023UN01-G AlarisTM GH Guardrails Syringe Pump with Plus Software 8002MED01-G AlarisTM GH Syringe Pump with Plus Software 8002TIG01 AlarisTM GH Guardrails Syringe Pump with Plus Software 8002TIG01-G AlarisTM GS, Universal 80013UN00 AlarisTM GS, Universal, RS232 80013UN01 AlarisTM PK Syringe Pump, Universal 80053UN01 AlarisTM TIVA, Universal, RS232 80043UN01
  • Manufacturer
    CareFusion International

Manufacturer

CareFusion International