Events

Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS, FORMULA PLUS and FORMULA THERAPY. ANVISA Registration Number: 80102510346 / / / Risk Class: III - High Risk /// Affected Model (s): All models mentioned above. // series: vide portal Anvisa - Alert 2048. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L. 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
    2049
  • 날짜
    2016-11-18
  • 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
    0
  • 원인
    Hemodialysis device - three events have been reported that resulted in fire on three different machines; during the disinfection cycle of one of the machines and before use in the patient on two machines, which were connected. based on internal investigations at the company bellco srl, it was determined that the battery charge frame would be the source of the problem in two of these events. the source of the problem in the third machine could not be definitively determined because of the magnitude of the damage in the frame, although the available evidence is consistent with the other two events. the manufacturer has found that disconnecting the battery charging frame eliminates the possibility of failure mode while a permanent solution is being implemented.
  • 조치
    Risk classification: III.///Classification of the field action: Update, correction in the field. Update, field correction and subsequent recall, where the products will be exported to Memphis later. / / Field action code: AC05 /// Recommendations to users and patients: The applicable Shares are described in Attachments A, B and C issued by the manufacturer and may be carried out by the technician of the acquiring company or through the Technical Assistance of MEDNEX BRASIL, Rua Sampaio Viana, 277 - 9 ° andar, CEP 04004-000 - Paraíso, São Paulo - SP, Phone: + 55 11 2039-1330 company is authorized and trained by the manufacturer Bellco.

Device

Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA