Events

Retiro De Equipo (Recall) de Device Recall CDI 500 Monitor

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
    60152
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1378-2012
  • Fecha de inicio del evento
    2012-02-03
  • Fecha de publicación del evento
    2012-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104615
  • 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
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Causa
    Replacement of the sbc batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house service procedure because some systems may be relying on batteries beyond their useful life.
  • Acción
    On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovascular Systems representative or call 1-800-521-2818 with questions or concerns, to check the last time system batteries were replaced, or to schedule maintenance for systems approaching 10 years.

Device

Device Recall CDI 500 Monitor
  • Modelo / Serial
    500AVHCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/ Saturation probe: 1001, 1005, 1007, 1011-1022, 1024, 1028, 1032, 1036, 1038, 1039, 1041-1044, 1046, 1047, 1049-1053, 1059, 1063, 1066-1071, 1075, 1096, 1097, 1101, 1103-1105, 1111-1113, 1115, 1130, 1133-1140, 1146-1152, 1166-1168, 1181-1185, 1216-1220, 1231-1235, 1244-1248, 1254, 1255, 1261-1264, 1270-1274, 1285, 1286-1289, 1295-1299, 1304-1309, 1312-1315, 1321, 1332-1334, 1340-1344, 1350-1354, 1357, 1358, 1379-1383, 1389-1393, 1399-1408, 1414-1418, 1421, 1422, 1424-1433, 1439-1443, 1449-1453, 1459-1463, 1466, 1479, 1480, 1494, 1525, 1554, 1597-1601, 1605, 1617-1631, 1637-1646, 1657-1661, 1672-1676, 1682-1686, 1697-1701, 1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905, 1916-1920, 1926-1930, 1936-1940, 1953-1974, 1976-1985, 2028-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189, 2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 2295-2298, 2313-2321, 2323-2329, 2338-2354, 2357, 2368, 2370-2375, 2377, 2392, 2403-2408, 2417-2426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517, 2521-2525, 2541-2556, 2565-2582, 2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661, 2662, 2664-2680, 2689-2691, 2695, 2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802, 2805-2808, 2815-2820, 2837-2839, 2846-2849, 2865-2870, 2880-2889, 2892-2895, 2906-2908, 2913-2915, 2920, 2921, 2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 3441-3447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 3590-3609, 3612-3619, 3624-3628, 3636-3639, 3643-3645, 3669-3681, 3698-3703, 3715, 3716, 3722-3726, 3738-3744, 3753-3757, 3769-3780, 3784-3787, 3799-3804, 3811-3816, 3827-3830, 3838-3841, 3852-3881, 3892-3899, 3902-3906, 3912-3921, 3924-3931, 3937-3952, 3962-3965, 3971-3974, 3986-3989, 3995-3998, 4006-4029, 4038-4043, 4050-4055, 4070-4075, 4082-4089, 4096-4099, 4105-4108, 4114-4131, 4143-4148, 4169-4185, 4203-4212, 4219-4224, 4230-4241, 4260-4280, 4290-4299, 4307-4310, 4318-4323, 4335-4344, 4351, 4352, 5001-5010, 5036-5039, 5048-5056, 5065-5077, 5082-5085, 5094-5101, 5118-5125, 5142-5149, 5158-5169, 5178, 5179, 5190, 5197, 5198, 5210-5213, 5222-5225, 5238-5245, 5250-5253, 5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344, 5354-5356, 5370-5374, 5383, 5385, 5386, 5516-5526, 5532-5541, 5557-5561, 5584-5587, and 5589-5592.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, WV, WA, and WI and the countries of Japan, Germany, Barbados, Saudi Arabia, Columbia, Uruguay, Ecuador, Trinidad, Costa Rica, Paraguay, Panama, Belgium, Jordan, Libya, Mexico, Brazil, Honduras, Canada, Korea, Dominica Republic, El Salvador, Guatemala, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Taiwan, Philippines, Mexico, Thailand, Vietnam, and South Africa.
  • Descripción del producto
    CDI Blood Parameter Monitoring System 500, 500AVHCT. || Intended for use during cardiopulmonary bypass procedures.
  • 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