Events

Infusion Pump SAPPHIRE 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Q Core Medical 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
    I1608-328
  • 사례 연번
    2014EBC-0011258
  • 날짜
    2016-08-04
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • 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 it has identified deviations detected by users in the npt mode and programming cones, if the pump is not connected to ac power and uses the backlight function, which can lead to confusion for users and potentially serious adverse events on the patient.

Device

Infusion Pump SAPPHIRE
  • 모델명 / 제조번호(시리얼번호)
    SAPPHIRE MULTI THERAPY - 15031-000-0001 and 15031- 000-0032, software version 13.21.1
  • 제품 설명
    Delivery controlled through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline sera, total parenteral nutrition (TPN), lipids, IV medicine, epidural medication, blood and blood products. The SAPPIHRE pump includes the following infusion modes for all intended uses: continuous, intermittent, TPN, PCA, multi-step and epidural. Labomba is indicated to be used both by health professionals in a clinical environment and by home users in an ambulatory environment. The SAPPHIRE pump is designed to follow the patient through the various areas of care and is suitable for use in different configurations
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd