Events

HomeChoice/HomeChoice PRO Automated PD System 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Baxter Healthcare SA 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(11)
  • 날짜
    2014-03-14
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/homechoice-homechoice-pro-automated-pd-system&id=baccf925-9782-6eee-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
    Baxter healthcare is issuing a field safety notice (fsn) to inform users of the homechoice/homechoice pro systems of an additional warning to be included in the device product labeling. the warning relates to unintended increased intraperitoneal volume (iipv) in specific patient populations using peritoneal dialysis therapy.
  • 조치
    1. Follow the manufacturer’s recommendations in the attached FSN. A copy of the FSN (and warning instructions) should be kept with your HomeChoice user manual. 2. Ensure that relevant personnel, in particular home patients, receive a copy of the attached FSN and are made aware of the information contained in the FSN and additional warning instructions.  3. If you have distributed the devices to other healthcare professionals or organisations, please forward this notice accordingly.

Device

HomeChoice/HomeChoice PRO Automated PD System

Manufacturer

Baxter Healthcare SA