Events

Device Recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Perfusion Systems 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
    79058
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0645-2018
  • 사례 시작날짜
    2018-01-16
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161254
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • 원인
    Possible sterile barrier breach in the pouch of affinity nt cardiotomy venous reservoir stand alone uncoated and affinity nt cardiotomy venous reservoir stand alone trillium coated products.
  • 조치
    Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. Customer Actions: Please review your inventory for product affected by this issue. 1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory. 2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. 3.) Complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For further questions, please call (763) 526-2494.

Device

Device Recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
  • 제품 설명
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 || The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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