Events

Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions into infusion pumps) - Code 441702 - Registration 80136990755 - Lots 15G21LA335, 15H21LA383, 15H21LA384, lSH24LA385 and 15H31lA398 and Enteral Nutrition Equipment for infusion pumps B.Braun (Infusomat Space Set Enteral Air) Code 402111 - Registration number 80136990733, lot 15H2SLA388 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Laboratórios B. Braun S.A. 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
    1697
  • 날짜
    2015-10-09
  • 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
    According to the manifestation of the company, this condition can compromise the correct functioning during the removal of the pump equipment, which can result in free flow, in case the health professional does not perform the standard procedure, which consists of closing the clamp and disconnect the patient's equipment before removing it from the pump.
  • 원인
    During an inspection by the production supervisor (assembly area), the erroneous assembly of the green infusomat clamp component was identified by a specific employee. although the employee was trained, he was assembling the tongs inverted. 100% of the employee's production was inspected and the problem was confirmed.
  • 조치
    The company is carrying out the collection of the lots mentioned in this alert and requests the interruption of the use of said batches, the segregation thereof, as well as the information to the B. Braun SA laboratories of the quantities of existing units of each batch number for the process of recollection

Device

Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions int...

Manufacturer

Laboratórios B. Braun S.A.