Events

Plum 360 infusion 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 ICU 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
    2018-02-15
  • 사례 출판 날짜
    2018-02-15
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/plum-360-infusion-pumps-user-actions-required-to-prevent-risk-of-interrupted-infusion-or-delay-to-treatment
  • 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 icu medical (formerly hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (mda/2018/006).
  • 조치
    Identify affected pumps, which were manufactured from 29 April 2015 to 25 October 2016 inclusive – see the spreadsheet listing device serial numbers which accompanies this Medical Device Alert and the manufacturer’s Field Safety Notice (FSN). If you are still unsure, contact the manufacturer. Inspect affected pumps as detailed in the FSN. If a loose connectivity engine module or blank display is found, remove the pump immediately from service, and contact manufacturer for repair. If the pump powers down without an alarm, use an alternative pump, and contact manufacturer for repair. Assist manufacturer to schedule appointments for inspection/repair and ensure pumps are made available to manufacturer for inspection/repair at the scheduled time/date. Ensure you have read the Field Safety Notice and have completed and returned the acknowledgement form as currently the manufacturer has not received sufficient responses

Device

Plum 360 infusion pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.
  • Manufacturer
    ICU Medical

Manufacturer

ICU Medical
  • 제조사 주소
    ICU Medical Customer Service Tel: 020 3357 9400
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    MHRA