Enteral Nutrition Equipment for use with Macrogotas Infusion Pump, Hazard Class II, Brand: Baxter, Registro: 80145240369 .. Serial Numbers: SEE ANNEX - DISTRIBUTION LIST 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch. 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
    1507
  • 날짜
    2014-12-16
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    As described in the Instructions for Use of the Colleague Pump, they are able to infuse medications, solutions, parenteral nutrition, lipids, blood and blood components. It is important to note that, according to the manufacturer, the Colleague Infusion Pump is NOT designed for enteral administration (SEE CUSTOMER LETTER). /// According to the manufacturer's information there is no risk to patients of injuries. A failure in the amount of solution administered may occur due to flow failure during administration. In this case the patient may present with adverse symptoms such as abdominal distension, diarrhea and hyperperistalse.
  • 원인
    Identified by the company the incomplete validation of the equipment according to the requirement contained in the specifications of the colleague infusion pump. in this case, flow rate and volume may fail during enteral use. in use, it is also possible to have faults in closing the flow control valve of the colleague pump (code 808: 03).
  • 조치
    The company issues a safety alert to customers stating that when using the Colleague Infusion Pump teams, appropriate medical follow-up should be requested. Customers listed on the distribution map (SEE ANNEX), must fill out the Customer Response Form (SEE CLIENT LETTER) and send the company. In case of being a distributor, the orientation is to pass the Letter of clarification to your customers who have purchased the material.

Manufacturer