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Diacap® Ultra dialysis fluid filter 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 B. Braun Avitum AG 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 ID
    MDA/2013/033
  • 사례 연번
    CON272262
  • 날짜
    2013-05-10
  • 사례 출판 날짜
    2013-05-10
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272262?tabName=allTabs
  • 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
    Risk of a gradual increased fluid removal, which may cause symptoms of hypotension during dialysis treatment. ultrafiltration deviations may not be immediately detected by the machine. this is due to a decrease in the residual moisture of the filter membrane, which can cause a higher fluid removal from the patient than initially selected. it has been noted that over time the residual moisture of the membrane used in the diacap ultra dialysis fluid filter decreases leading to an alteration in the membrane permeability, which in turn affects the device flow resistance. when used clinically, the altered functionality of the device can lead to excess fluid of up to 230 ml/hr, being removed under worst case conditions. although the haemodialysis system will alarm at a set value beyond the pre-set ultrafiltration rate, the higher ultrafiltration rate has the potential to cause symptoms of hypotension in some patients.
  • 조치
    Identify quarantine and do not use affected devices. Ensure that all staff are aware of the manufacturer’s Field Safety Notice (FSN) dated 22 February 2013. Develop a system to ensure that these devices are not used more than 10 months from the date of manufacture, until the manufacturer advises otherwise. Return the ‘confirmation of receipt’ form in the FSN to the manufacturer. Contact B. Braun Medical Ltd, Sheffield to arrange replacement of affected product.

Device

Diacap® Ultra dialysis fluid filter
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Diacap® Ultra dialysis fluid filter. Product code: 7107366. All devices that are more than 10 months from the date of manufacture are affected. This device is used as a bacteria and pyrogen filter for dialysis fluid purification, as well as for processing substitution solution for online haemodiafiltration and haemofiltration procedures. The date on the label is in the format YYYY-MM e.g. 2012-07 for July 2012. The month of manufacture in this case is July 2012 which should be counted as month one when calculating the age of filters. Therefore, product manufactured in July 2012 should not be used after April 2013. See Field Safety Notice for further information.
  • Manufacturer
    B. Braun Avitum AG

Manufacturer

B. Braun Avitum AG