Events

Rappel de Device Recall CDI 500 Monitor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Terumo Cardiovascular Systems Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60152
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1379-2012
  • Date de mise en oeuvre de l'événement
    2012-02-03
  • Date de publication de l'événement
    2012-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105615
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    500AHCT CDI Blood Parameter Monitoring TBD System 500 with Arterial blood parameter module and Hematocrit/ Saturation probe: 1023, 1025-1027, 1029-1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095, 1098-1100, 1102, 1106-1110, 1114, 1116-1129, 1131, 1132, 1141-1145, 1153-1165, 1169-1180, 1186-1191, 1194-1210, 1212-1215, 1221-1230, 1236-1243, 1249-1253, 1256-1260, 1265-1269, 1275-1284, 1290-1294, 1300-1303, 1310, 1311, 1316-1320, 1322-1331, 1335-1339, 1345-1349, 1359-1378, 1384-1388, 1394-1398, 1409-1413, 1419, 1434-1438, 1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493, 1495-1503, 1505-1520, 1528, 1531-1553, 1555-1558, 1567-1596, 1607-1616, 1632-1636, 1647-1656, 1667-1671, 1677-1681, 1687-1696, 1702-1711, 1717-1721, 1728-1732, 1738-1753, 1759-1775, 1777-1786, 1790-1794, 1796-1804,1810-1814, 1820-1829, 1831-1843, 1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915, 1921-1925, 1931-1935, 1941-1950, 1975, 1986-2015, 2017-2022, 2024-2027, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118-2122, 2132-2137, 2143- 2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259, 2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312, 2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2681-2688, 2692-2694, 2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814, 2821-2836, 2840-2845, 2850-2859, 2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124, 3126-3130, 3136-3138, 3147-3151, 3154, 3163-3168, 3183-3189, 3197-3213, 3221-3224, 3229-3231, 3233-3237, 3246, 3247, 3250-3260, 3269-3286, 3290, 3307-3313, 3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479, 3483-3488, 3491-3499, 3504-3508, 3511-3517, 3519-3533, 3536-3540, 3546-3570, 3574-3589, 3610, 3611, 3620-3623, 3632-3635, 3640-3642, 3649-3660, 3662-3668, 3682-3697, 3704-3714, 3717-3721, 3727-3737, 3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826, 3831-3837, 3842-3851, 3882-3891, 3900, 3901, 3907-3911, 3922, 3923, 3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005, 4030-4037, 4044-4049, 4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142, 4149-4168, 4186-4202, 4213-4218, 4225-4229, 4242-4259, 4281-4289, 4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556, 5562-5564, 5566, 5569, 5571, 5572, 5574-5577, 5581-5583, and 5593-5600.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    CDI Blood Parameter Monitoring System 500, 500AHCT. || Intended for use during cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA