Events

SynchroMed II Implantable Drug Infusion Pump 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
  • 날짜
    2017-09-15
  • 사례 출판 날짜
    2017-09-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170915.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic synchromed ii implantable drug infusion pump medical device manufacturer, medtronic, has issued a medical device safety alert concerning its synchromed ii implantable drug infusion pump [model numbers: 8637-20 and 8637-40]. the manufacturer has received approval to implement a design change to the synchromed ii implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy. for pumps manufactured prior to this design change, analysis of the post-market data estimates the pump survivability specific to non-recoverable motor stall at six years post-implant to be 97.3% for pumps exposed to on-label drugs and 91.1% for pumps exposed to off-label drugs. the most common contributing factor to motor stall is shaft wear and this is observed in 59% of synchromed ii pumps returned and analyzed for motor stall. engineering testing estimates that the new design change addresses over 99% of shaft wear and will decrease the occurrence of motor stall. the manufacturer recommends the synchromed ii infusion system be used according to approved product labeling. reliability for synchromed ii pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication. according to the manufacturer, all synchromed ii pumps are now manufactured with the new design change, although there are limited quantities of these new devices in initial production. to ensure the patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. once there is sufficient inventory of the pumps with the new design, the manufacturer will no longer distribute pumps manufactured prior to this change. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 september 2017.

Device

SynchroMed II Implantable Drug Infusion Pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH