Events

Siemens BCS / BCS XP System 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Healthcare Diagnostics Products GmbH. 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
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false high pt % of the norm or false low pt inr values. these false short clotting times were observed with turbid, hemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre- peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms. an example is given in figure 1. (left: expected reaction curve; right: erroneous evaluated reaction curve). .

Device

Siemens BCS / BCS XP System
  • 모델명 / 제조번호(시리얼번호)
    BCS 10454728 (BCS RECONDITIONED) 10454729 (BCS RECONDITIONED) 10454742 (BEHRING COAGULATION SYSTEM) 10459303 (BCS RECONDITIONED) 10460659 (BCS INSTRUMENT) 10461881 (BCS INSTRUMENT) BCS XP 10459330 (BCS XP SYSTEM, COMPLETE) 10462449 (BCS XP ANALYZER SYSTEM) 10461894 (BCS XP) 10470625 (BCS XP REFURBISHED) Dade Innovin 10284500 10445704 10445705 10445706 10465673 10465674
  • Manufacturer
    Siemens Healthcare Diagnostics Products GmbH.

Manufacturer

Siemens Healthcare Diagnostics Products GmbH.