Events

Device Recall Medtronic MiniMed Paradigm Silhouette and SureT infusion sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic MiniMed Inc. 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
    69720
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0524-2015
  • 사례 시작날짜
    2014-11-04
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131422
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Set, administration, intravascular - Product Code FPA
  • 원인
    Tubing may detach at the connect/disconnect location on the minimed silhouette and minimed sure-t infusion sets. detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. this can lead to hyperglycemia, and diabetic ketoacidosis (dka).
  • 조치
    Medtronic sent an Urgent Medical Device Correction letter to patients dated November 5, 2014, healthcare professionals October 30, 2014, and distributors October 2014. Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. Medtronic will give you instructions on how to return the affected infusion set. The letter states that Medtronic has identified a solution and is working to incorporate improvements within the coming weeks. In the meantime, you will still be able to order these infusion sets. If you would like to try another type of infusion set instead, we can exchange your infusion sets with the MiniMed Quick-set or MiniMed Mio. To learn more about these infusion sets or to find additional information about this notification, please call us or visit www.medtronicdiabetes.com/tubingdetachment.

Device

Device Recall Medtronic MiniMed Paradigm Silhouette and SureT infusion sets
  • 모델명 / 제조번호(시리얼번호)
    This field correction involves all models of Silhouette and Sure-T insulin infusion sets.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lativa, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • 제조사 주소
    Medtronic MiniMed Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • 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
    USFDA