Events

System for Fluid Heating RANGER 245 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 3M Health Care 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
    I1510-485
  • 사례 연번
    2010DM-0005465
  • 날짜
    2015-10-29
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • 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 operation of the medical device can be affected by the close use of finger-way radios, causing the activation of an audible and visual alarm of high or low temperature or the unstable operation thereof, leading to the occurrence of adverse events or delays in the patient care.

Device

System for Fluid Heating RANGER 245
  • 모델명 / 제조번호(시리얼번호)
    RANGER 245
  • 제품 설명
    The RANGER heating system is designed to heat blood, blood products and liquids. The heating system for blood and fluids RANGER is a device composed of a heating unit and a disposable equipment for the administration of blood and fluids intravenously (IV), the heating system RANGER is designed to heat blood, blood products and liquids and achieves a speed of MVA flow rate at 500ml per minute. Two disposable equipment for blood and fluids can be obtained: one for normal flow applications and one for high flow applications. These disposable equipment, designed for use in reusable dewaxing units, are sterilized, do not contain latex and are for single use only.
  • Manufacturer
    3M Health Care

Manufacturer

3M Health Care