Events

Aquarius haemofiltration machines 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Edwards Lifesciences Ltd, supplied by Baxter Healthcare 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/2010/039
  • 날짜
    2010-05-12
  • 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-aquarius-haemofiltration-machines-follow-instructions-carefully
  • 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
    Reports have been received of the wheels breaking due to wear or improper use. There is a risk of the machine toppling or falling over, which can cause injury and therapy interruption.Damage to the wheels (which are referred to in the attached technical bulletin as ‘rollers’) may not have been detected during routine servicing, so it is essential to check them regularly. If the wheels are damaged, the machine should be taken out of service and repaired.Appendix to MDA/2010/039 - Edwards Lifesciences: Technical bulletin (74Kb)
  • 원인
    (edwards lifesciences ltd, supplied by baxter healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (mda/2010/039).
  • 조치
    Users should ensure that machines are transported in accordance with the instructions in the operating manual.Maintenance staff should ensure that:they are aware of the recent technical bulletin (see appendix), which describes specific wheel inspections all wheels are inspected for wear and/or damage and appropriate action is taken, as required.Users should refer to the instructions in the operating manual in order to minimise damage to the machine’s wheels, which is most likely to be caused by movement of the machine over steps, stairs or other uneven surfaces. The instructions state: ‘To move or transport the Aquarius it is necessary to release the locking tabs on the wheels. The Aquarius can then be rotated and freely moved about. To move the Aquarius over steps or stairs the locking tabs must be released. The system should be tilted, lifted, and carried by at least three people. The Aquarius must not be pushed over uneven floors’.

Device

Aquarius haemofiltration machines
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    All Aquarius haemofiltration machines.Manufactured by Edwards Lifesciences Ltd and supplied by Baxter Healthcare.Aquarius haemofiltration machines used to be manufactured and badged by Edwards Lifesciences. However, Baxter Healthcare took over responsibility for the supply and servicing of Aquarius Haemofiltration Devices in September 2009, following their acquisition of the Edwards Haemofiltration business.
  • Manufacturer
    Edwards Lifesciences Ltd, supplied by Baxter Healthcare

Manufacturer

Edwards Lifesciences Ltd, supplied by Baxter Healthcare
  • 제조사 주소
    Edwards Lifesciences Andleeb Arshad Sherwood House 78-84 London Road Newbury Berkshire RG14 1LA Tel: 0870 606 2040 Fax: 0870 606 2050Email: andleeb_arshad@edwards.com
  • 제조사 모회사 (2017)
    Edwards Lifesciences Corporation
  • Source
    MHRA