SYNCHROMED II - PROGRAMMABLE PUMP 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 MEDTRONIC OF CANADA LTD. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    43454
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-03-05
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Provide important new information regarding overinfusion associated with the synchromed ii implantable pump.Overinfusion is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs it will result in a volume discrepancy at pump refill where the volume withdrawn from the pump is less than the volume expected. overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk medtronic is not recommending prophylactic replacement of pumps.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8637 (Lot serial: All Lots)
  • 제품 설명
    SYNCHROMED II - PROGRAMMABLE PUMP
  • Manufacturer

Manufacturer

  • 제조사 주소
    BRAMPTON
  • 제조사 모회사 (2017)
  • 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
    HC