Events

Retiro De Equipo (Recall) de Device Recall Sarns Modular Perfusion System 8000

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Terumo Cardiovascular Systems Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1453-2012
  • Fecha de inicio del evento
    2012-03-21
  • Fecha de publicación del evento
    2012-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108162
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA