Events

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 Hospira 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
  • 사례 연번
    MDA/2013/006
  • 날짜
    2013-02-20
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-infusion-pumps-plum-a-and-a-3-family-of-infusers-risk-of-interruption-in-therapy
  • 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
    Risk of interruption to treatment.If the pump is running on mains power and the software detects that the battery cannot be fully recharged, an alarm will sound and the infusion will stop.If this occurs the “E321” error message will be displayed.The MHRA continues to investigate this and other recent field safety corrective actions.
  • 원인
    (hospira) if pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (mda/2013/006).
  • 조치
    Identify affected pumps. Consider using an alternative device, particularly if an interruption to an infusion could compromise patient safety. If an alternative is not available, follow the advice in the manufacturer’s Field Safety Notice (845Kb) (dated 19 February 2013) Ensure staff also follow the advice in other Field Safety Notices issued by the manufacturer for the following problems:  Volume control knob (457Kb) Door roller assembly (2746Kb) Distal pressure sensor calibration (61Kb) Fluid ingress (991Kb) Fluid shield diaphragm (84Kb) Distal pressure sensor pin fracture (92Kb) Recycling / rebooting (3252Kb)

Device

Infusion pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Infusion pumps: Plum A+ single channel infuser systems.Manufactured by Hospira.Product codes: 11005, 11971, 12391, 20792.The following single channel infuser systems are affected by this alert:Plum A+ hyperbaric infusion system. Affected product code: 11005 Plum A+ single channel infusion system. Affected product codes: 11971 + 12391 Plum A+ infusion pump. Affected product code: 20792.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • 제조사 주소
    John McIlvaney Customer Services Manager Hospira UK Queensway Royal Leamington Spa CV31 3RW Tel: 0800 028 7304 Fax: 0800 028 7305Email: custserv@hospira.com
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    MHRA