Events

PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Fresenius Vial 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
    910
  • 날짜
    2008-04-17
  • 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
    The company Fresenius Kabi Brasil Ltda informed in a letter of communication sent to the Anvisa's Unit of Technovigilance that it will be sending letters of communication to clarify to its clients about the correct positioning of the equipment in the infusion pumps for enteral feeding. The company also informed that it will be providing to GQUIP / ANVISA (Equipment Technology Management) to change the legal information of use instructions contained in the Product Use Manual.
  • 원인
    If the equipment is improperly adjusted in the pump, there is a risk of free flow of fluid and consequent overdosage of enteral nutrition.
  • 조치
    UTVIG / ANVISA recommends that persons responsible for the use of pumps: (1) Identify the products listed in their inventory; (2) Check whether all those directly involved in the operation of the infusion pumps (doctors, nurses, patient's relatives, etc.) are adequately trained; (3) Ensure that the instructions contained in the user manual are available and easily accessible to the pump operators; (4) Ensure that pump operators are performing visual inspection of these equipment and recording any observed nonconformities; (5) Ensure that pump operators are following the manufacturer's instructions for installation of the equipment (see Annex 01).

Device

PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Fresenius Vial

Manufacturer

Fresenius Vial