Events

Device Recall Sarns Modular Perfusion System 8000 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
    60774
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1453-2012
  • 사례 시작날짜
    2012-03-21
  • 사례 출판 날짜
    2012-04-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108162
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    Terumo received multiple reports of malfunctions of the cardioplegia and arterial monitors for the sarns modular perfusion system 8000. upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. the compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, po.
  • 조치
    TERUMO sent an URGENT MEDICAL DEVICE RECALL- SAFETY ADVISORY to all consignees on March 21, 2012 via Federal Express. Terumo issued the safety advisory to remind users how to intervene if they experienced intermittent or complete loss of pressure display on the arterial monitor or cartiplegia monitor, or a related pump stop. Customers were asked to review the Medical Device Correction notice, assure that all users are aware of the notice, confirm receipt of the communication by faxing the attached Customer Response Form to 1-800-292-6551. For questions regarding this recall call 1-800-521-2818.

Device

Device Recall Sarns Modular Perfusion System 8000
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 16413; Lot numbers/serial numbers: 1, 2, 3, 246553, 249652, 253943, 256867, 258565, 263614, 269567, 276866, 279012, 281191, 288150, 290070, 296227, 298374, 303142, 308343, 309896, 320618, 323004, 325187, 327295, 329342, 330149, 331788, 333055, 335139, 337482, 341259, 343978, 349845, 352311, 355122, 358382, 358383, 360213, 367161, 370516, 376523, 378092, 381115, 383781, 389150, 392116, 395215, 400085, 400086, 400833, 401042, 401570, 401675, 402124, 402264, 403141, 403142, 403545, 403712, 403719, 404180, 404359, 405057, 405333, 405712, 405859, 406219, 406366, 406512, 406717, 407049, 407241, 407338, 407620, 407637, 407813, 407902, 408362, 408526, 408666, 409214, 409283, 409297, 409422, 409571, 410057, 410250, 410397, 411130, 411208, 411295, 411563, 412058, 412213, 412890, 413161, 413182, 414317, 414363, 414815, 415034, 415250, 415670, 416854, 417128, 417433, 417435, 417561, 418217, 418779, 418911, 419146, 419556, 420313, 420687, 421632, 421834, 422083, 422739, 423663, 424267, 426877, 429622, 430398, 438156, 439123, 444234, 445779, 448180, 452751, 455760, 458517, 461157, 463964, 467455, 468739, 479124, 483205, 483635, 487380, 9434006, 93326004, 94059004, 94115004, 94123004, 94123005, 94130005, 94143005, 94143006, 4158005, 94175005, 94179005, 94179006, 94186005, 94186006, 94200005, 4200006, 94206005, 94206006, 94234006, 94249006, 94284006, 94297006, 94304006, 94311006, 94318006, 95006005, 95048006, 95059006, 95067006, 95086006, 95094006, 95108006, 95114006, 95122006, 95171006, 95174006, 95215006, 95223006, 95234006, 95244006, 95265006, 95282006, 95305006, 95312006, 95345006, 95356006, 96043006, 96091 006, 961 03006, 961 08006, 96143008, 96158008, 96162008, 96200008, 96228008, 96236008, 96241008, 96253008, 96277008, 96295008, 96313008, 96344008, 96348008, 96353008, 97004008, 97006008, 97007008, 97052008, 97066008, 97087008, 97113008, 97120008, 97132008, 97141008, 97156008, 97157008, 97161008, 97199008, 97223008, 97230008, 97238008, 97261008, 97279008, 97302008, and 97308008.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
  • 제품 설명
    Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) || The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA