Events

Device Recall Terumo Perfusion System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    49604
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0296-2009
  • 사례 시작날짜
    2008-05-23
  • 사례 출판 날짜
    2008-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73911
  • 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
    Heart Lung Console - Product Code DTQ
  • 원인
    The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.
  • 조치
    U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008. For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818.

Device

Device Recall Terumo Perfusion System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 2264, 2281, 3077 through 3082, 3084 through 3088, 3092, 3094 through 3110, 3112 through 3115, 3117, 1932x, 1939x through 1943x, 1950x , 1951x, 1954x, 1973x, 1979x, 1980x, 1982x, 1990x, 1994x, 2000x, 2009x, 2014x through 2064x, 2066x through 2163x, 2194x through 2222x, 2225x through 2232x, 2280x, 2282x, 2283x, 2290x, 2294x, 2295x, 2298x through 2301x, 2303x, 2305x, 2306x, 2309x through 2311x, 2313x through 2315x, 2318x, 2319x, 2322x through 2324x, 2330x through 2332x, 2334x through 2347x, 2350x through 2467x, 2469x through 2471x, 2473x t hrough 2503x, 2505x, 2507x through 2529x, 2533x, 2536x, 2539x through 2541x, 2543x through 2551x, 2553x through 2572x, 2574x through 2583x, 2585x through 2609x and 2611x through 2624x.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.
  • 제품 설명
    Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195274. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base. || Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA