Events

Solution for Dialysis in Renal Replacement Therapy 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Gambro Renal Products, 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
    R1607-274
  • 사례 연번
    2010DM-0005701
  • 날짜
    2016-07-07
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 has detected the presence of leaks near the upper part of the bags of the device, which may cause microbial contamination of the dialysate, leading to potentially adverse events occurring in patients.

Device

Solution for Dialysis in Renal Replacement Therapy
  • 모델명 / 제조번호(시리얼번호)
    105351 - PRISMASATE BGK 2/0, lots 1000123133 and 1000128162 distributed between 10/27/2015 and 01/30/2016.
  • 제품 설명
    Adjuvant solution of hydro-electrolyte balance and PH in patients under renal substitution contains. The PRISMASATE solutions are sterile, to be used in patients under continuous renal replacement in patients with acute renal failure, and in other cases, when fluid or solute removal is required, as in cases of acute poisoning due to medications or drugs that can be dislodged, PRISMASATE does not enter contact with the patient's bloodstream. FIRMASATE solutions are sterile dialysis solutions to be used in continuous renal replacement therapy procedures during the treatment of renal insufficiency and in other indications where the removal of liquids or solutes is required, as in poisoning, which are dialysable.
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.