Events

Recall of Device Recall CDI 500 Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60152
  • Event Risk Class
    Class 2
  • Event Number
    Z-1378-2012
  • Event Initiated Date
    2012-02-03
  • Event Date Posted
    2012-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104615
  • Notes / Alerts
    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.
  • Extra notes in the data
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Reason
    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
  • Model / 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    CDI Blood Parameter Monitoring System 500, 500AVHCT. || Intended for use during cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA