Events

MEDTRONIC PERFUSION TUBING PACKS 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
    72025
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2736-2015
  • 사례 시작날짜
    2015-08-18
  • 사례 출판 날짜
    2015-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139597
  • 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
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • 원인
    Hemocor high performance hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. these potentially affected units have been distributed as stand-alone devices and in specific lots of medtronic perfusion tubing packs.
  • 조치
    Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated August 2015. The letter was addressed to "Risk Manager". The letter described the problem and the product involved in the recall. Informed consignees that no action is needed for product that has been used, but patients should continue to be managed in accordance with their standard patient management protocol. For unused product they recommend to immediately quarantine and return the affected product to Medtronic. Contact Customer Service at 800-854-3570 and reference RADAR #253277 to initiated a return and credit of product. Requested consignees to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If the product has been forwarded to another facility, consignees are advised to notify that facility. For questions contact Medtronic Lifeline Technical Services at 877-526-7890 or your Medtronic representative.

Device

MEDTRONIC PERFUSION TUBING PACKS
  • 모델명 / 제조번호(시리얼번호)
    209050007 209087876 209107465 209135076 209162502 209195930 209241496 209241613 209270018 209270092 209297994 209298091 209298094 209310403 209326025 209373545 209388464 209396017 209401269 209401312 209415313 209431890 209464644 209512240 209556873 209621268 209644548 209653827
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
  • 제품 설명
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, || TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, || TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, || M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status.
  • 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