Events

HOMECHOICE FOR DIALISE PERITONEAL BAXTER - Pack containing 01 System for Dialysis Peritoneal, model Homechoice, brand Baxter. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BAXTER HOSPITALAR LTDA 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
    685
  • 날짜
    2003-01-13
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    Although the company claims to have no reported patient harm associated with this occurrence, Baxter calls for careful monitoring of patients with low infusion volume before making clinical decisions based on the volume of ultrafiltrate shown through the HomeChoice System display. To monitor the fluid balance of the HomeChoice System when using very low filtrate volumes, the physician should rely on a physical examination of the patient. In addition, the volume of ultrafiltrate indicated by the HomeChoice System should be checked in order to make any necessary adjustment to the therapy in order to maintain the patient's dry weight. 02/17/2003 - The Tecnovigilâcia / ANVISA unit is checking the information provided by the company, regarding the technical procedures of the modifications with the customers.
  • 원인
    The company baxter hospitalar ltda informs about the use of the homechoice system, considering the latest version of the software 8.51, initially released in june 2002. this notice aims to notify doctors about the possibility of low volumes of ultrafiltrate when using low volume mode in automatic peritoneal dialysis (apd) therapy. under the conditions of use of low volume mode (infusion volume less than 200 ml), the equipment has a lower drained volume than the actual one. thus, if the physician considers only the volume indicated by the equipment may take improper conduct, increasing the ultrafiltration. such a measure may favor volume depletion for the patient. therefore, it is recommended that the conduct be based on physical examination of the patient, especially considering body weight and blood pressure.
  • 조치
    Baxter Hospitalar Ltda, an affiliate of Baxter Healthcare Corporation in Brazil, hereby informs that it is sending the statement to the professionals / clinics that use the HomeChoice Peritoneal Dialysis System, as well as to its Home Care Coordinators. This release brings important information and aims to reduce any possibility of volume depletion during therapy with the HomeChoice System.

Device

HOMECHOICE FOR DIALISE PERITONEAL BAXTER - Pack containing 01 System for Dialysis Peritoneal, mod...

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA