Events

MEDRAD-BAYER Contrast Media Injector System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Bayer Medical Care Inc 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
    R1702-37
  • 사례 연번
    2016EBC-0015488
  • 날짜
    2017-02-14
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 states that the referenced devices may fail in occlusion situations, when it is more than one (1) year from the date of manufacture, therefore, there may be a saline leak as a radiopharmaceutical within the ionization chamber, resulting in in the application of an incomplete dose, which could result in the need to repeat the test or could also lead to possible exposure to radiation from the operator if the chamber is open, leading to delays in the procedure or possible adverse events on the patient and user.

Device

MEDRAD-BAYER Contrast Media Injector System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The MEDRAD INTEGO PET INFUSION SYSTEM is an infusion system for PET INTEGO is designed to administer accurate doses of radiopharmaceutical (RP) labeled with 18f-fluorodeoxyglucose (18f-fdg) or 18f-sodium fluoride (18f-naf) and physiological solutions of Usual use during diagnostic procedures using molecular imaging (median-nuclear) techniques. The INTEGO PET infusion system is also designed to effectively protect medical personnel from radiation exposure to fluoride-18 (18f) during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Medical Care Inc

Manufacturer

Bayer Medical Care Inc
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    NIDFSINVIMA