Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Gambro Lundia AB 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 039 11 16 000
  • 사례 시작날짜
    2016-11-06
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10188
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Baxter ag is issuing a voluntary urgent device correction for ak 98 dialysis machines due to two software issues. : i. the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of treatment. ii. the ultrafiltration supervision (ufs) may be put in an idle (non-functional) state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module.

Device

AK 98, 230V, Bio
  • 모델명 / 제조번호(시리얼번호)
    Product Name: AK 98, 230V, Bio Product Code: 115248 Serial Numbers: All (please refer to attached affected customers list).
  • 제품 설명
    Dialysis machine
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB