Events

Analyzer for Electrolytes and Gases RAPIDPOINT 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1706-206
  • 사례 연번
    2009DM-0004077
  • 날짜
    2017-06-02
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=84
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer establishes that the demographic information of the patient (surname, name, sex, date of birth) can be misassigned, when the patient's id field is left blank in multiple samples and a recovery of the patient's information is initiated, leading to present adverse events on patients due to confusion in the identification of results.

Device

Analyzer for Electrolytes and Gases RAPIDPOINT
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    RAPIDPOINT 400/405 instruments are analyzers for electrolyte and arterial gas tests at the patient's bedside by electrochemistry. It uses arterial or capillary blood samples. It provides the values of Ph, Pco2, Po2, Hco3-, CtCo2; Co-Oxi, Be (Ecf), O2sat, O2ct, Po2 (AA), Po2 (A / A), Fo2hb, Fmethb and Fcohb for blood gases and electrolyte analysis Na +, K +, Ca ++, Cl-, Li +, Glucose, Lactate , Hct And Hb. It is a system designed for critical patients in surgery, uci and emergencies that reports the values of the tests and communicates the results of the patient's clinics. The reagents used with the RAPIDPOINT equipment have their respective health records.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd

Manufacturer

Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd