Events

Baxter Coiled Tube Infusors 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Baxter 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(19)
  • 날짜
    2014-04-24
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/baxter-coiled-tube-infusors.-priority-2-warning&id=38d0f925-9782-6eee-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
    Following a review of customer complaints for over-infusion, baxter has identified an error in the directions for use for the coiled tube infusor system. as outlined in the attached fsn, direction for use #5 is incorrect for the coiled tube infusor. the nominal (labelled) flow rate is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use.  baxter has indicated that the following products which have been supplied to the irish market are impacted by this issue.  product codes product name 2c1071kjp single day infusor 2 ml/h system 2c1073kjp half day infusor sv 5 ml/h system 2c1080kjp multiday infusor 0.5 ml/h system.
  • 조치
    The IMB advise that users:  (1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached.  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Device

Baxter Coiled Tube Infusors
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Baxter Coiled Tube Infusors. Priority 2 – Warning
  • Manufacturer
    Baxter

Manufacturer

Baxter