Events

Device Recall Medtronic HMS PLUS, Hemostasis Management System with Heparin Assay Controls 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Disease Managment 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
    55169
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1537-2010
  • 사례 시작날짜
    2010-03-08
  • 사례 출판 날짜
    2010-05-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90214
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • 원인
    The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result.
  • 조치
    Medtronic issued an "Urgent Medical Device Notification" letter dated March 8, 2010 addressed to "Dear Valued Customer" and was sent to three locations at each customer site: Risk Management, Cardiovascular Surgery and Clinical Laboratory-Point of Care. The letter described the product and the issue, provided instructions for control and patient testing. The customer was requested to return an enclosed certificate as proof of notification. For further information, contact your Medtronic Sales Representative or call 1-763-391-9915.

Device

Device Recall Medtronic HMS PLUS, Hemostasis Management System with Heparin Assay Controls
  • 모델명 / 제조번호(시리얼번호)
    HMS Plus Catalog Number: 30514;  Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, International West (countries included in Western Europe and the Middle East), Australia and Canada.
  • 제품 설명
    Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. || A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • 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