Terumo Cardiovascular Systems Corporation: CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

Recall number

Z-2185-2011

Recalling firm

Terumo Cardiovascular Systems Corporation

Product

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

Status

Terminated

Initiated

2010-11-01

Posted

2011-05-12

Terminated

2014-07-31

Reason

The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracies. The CDI 101 and CDI 500 system are stand alone systems that are used during extracorporeal procedures to continuou

Root cause

Device Design

Action

The firm, TERUMO, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 27, 2010 to its customers. The letter described the product, problem and actionst to be taken. The customers were instructed to reveiw this notice; assure that customers are ware of this notice; confirm receipt of this notification by faxing the attached Customer Response Form, and place the attached stickers in a visible place in the Operators' Manuals, such as the inside of the front cover, if additional stickers are needed, the customers should contact Terumo CVS Customer Service at 1-800-521-2818. The letter states that when a displayed value is significantly different from expectations based on the clinical situatioin, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operatros manual. The letter also states "Please note that we are not recommending that you stop using your CDI monitor system." If you have any questions or concerns, please contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are from Monday-Friday, 8AM - 6PM EST.

Quantity

3260 units all models.

Distribution

Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.

Lot, serial or model codes

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1460, 1461, 1462, 1479, 1480, 1554, 1597, 1599, 1601, 1605, 1617, 1618, 1619, 1620, 1621, 1622, 1623, 1624, 1625, 1626, 1627, 1628, 1629, 1630, 1631, 1637, 1638, 1639, 1640, 1641, 1642, 1643, 1644, 1645, 1646, 1657, 1658, 1659, 1660, 1661, 1672, 1673, 1674, 1675, 1682, 1683, 1684, 1685, 1686, 1697, 1698, 1699, 1700, 1701, 1712, 1713, 1714, 1715, 1716, 1733, 1734, 1736, 1737, 1787, 1788, 1789, 1805, 1806, 1807, 1808, 1809, 1815, 1816, 1817, 1818, 1819, 1830, 1844, 1845, 1846, 1857, 1858, 1859, 1860, 1886, 1887, 1888, 1889, 1890, 1901, 1902, 1903, 1904, 1905, 1916, 1917, 1918, 1919, 1920, 1926, 1927, 1928, 1929, 1930, 1936, 1937, 1938, 1939, 1940, 1953, 1954, 1955, 1956, 1957, 1958, 1959, 1960, 1961, 1962, 1963, 1964, 1965, 1966, 1967, 1968, 1969, 1970, 1971, 1972, 1973, 1974, 1977, 1978, 1979, 1980, 1981, 1982, 1983, 1984, 1985, 2029, 2030, 2031, 2032, 2033, 2034, 2036, 2037, 2038, 2040, 2045, 2059, 2060, 2061, 2062, 2063, 2065, 2066, 2067, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2086, 2097, 2098, 2099, 2100, 2101, 2109, 2110, 2111, 2113, 2114, 2115, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2130, 2131, 2138, 2139, 2140, 2141, 2142, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2177, 2178, 2179, 2180, 2181, 2182, 2185, 2186, 2187, 2189, 2195, 2196, 2197, 2198, 2199, 2214, 2216, 2217, 2218, 2219, 2224, 2228, 2229, 2230, 2231, 2243, 2244, 2245, 2249, 2250, 2251, 2252, 2253, 2255, 2256, 2257, 2258, 2260, 2263, 2265, 2266, 2267, 2268, 2275, 2276, 2277, 2279, 2285, 2286, 2287, 2288, 2289, 2290, 2291, 2295, 2296, 2297, 2298, 2313, 2314, 2315, 2316, 2317, 2318, 2319, 2320, 2321, 2323, 2324, 2325, 2326, 2327, 2328, 2329, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2346, 2347, 2348, 2348, 2349, 2349, 2350, 2350, 2351, 2351, 2352, 2352, 2354, 2357, 2368, 2370, 2371, 2372, 2373, 2374, 2375, 2377, 2392, 2403, 2404, 2405, 2406, 2407, 2408, 2417, 2418, 2419, 2420, 2421, 2422, 2423, 2424, 2425, 2426, 2432, 2433, 2434, 2435, 2436, 2439, 2440, 2441, 2442, 2443, 2444, 2453, 2454, 2455, 2456, 2457, 2458, 2463, 2464, 2465, 2466, 2467, 2470, 2471, 2472, 2476, 2477, 2478, 2479, 2480, 2481, 2482, 2483, 2487, 2488, 2489, 2490, 2491, 2492, 2493, 2494, 2495, 2496, 2497, 2498, 2499, 2500, 2501, 2502, 2503, 2514, 2515, 2516, 2517, 2521, 2522, 2523, 2524, 2525, 2541, 2542, 2543, 2544, 2545, 2546, 2547, 2548, 2549, 2550, 2551, 2552, 2553, 2554, 2555, 2556, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 2599, 2600, 2601, 2602, 2603, 2629, 2630, 2631, 2632, 2633, 2635, 2636, 2637, 2638, 2639, 2640, 2641, 2642, 2646, 2647, 2656, 2661, 2662, 2664, 2665, 2666, 2667, 2668, 2669, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2680, 2689, 2690, 2691, 2695, 2696, 2701, 2702, 2703, 2704, 2705, 2706, 2707, 2708, 2710, 2711, 2712, 2713, 2714, 2715, 2716, 2722, 2723, 2724, 2725, 2726, 2727, 2737, 2742, 2743, 2744, 2745, 2746, 2747, 2757, 2758, 2759, 2760, 2761, 2762, 2763, 2764, 2765, 2766, 2767, 2768, 2769, 2770, 2771, 2772, 2773, 2783, 2784, 2788, 2793, 2794, 2795, 2802, 2805, 2806, 2807, 2808, 2815, 2816, 2817, 2818, 2819, 2820, 2837, 2838, 2839, 2846, 2847, 2848, 2849, 2865, 2866, 2867, 2868, 2869, 2870, 2880, 2881, 2882, 2883, 2884, 2885, 2886, 2887, 2888, 2889, 2892, 2893, 2894, 2895, 2906, 2907, 2908, 2913, 2914, 2915, 2920, 2921, 2924, 2925, 2926, 2937, 2938, 2939, 2940, 2942, 2943, 2944, 2945, 2946, 2947, 2952, 2958, 2959, 2960, 2961, 2962, 2963, 2964, 2965, 2966, 2967, 2968, 2969, 2970, 2971, 2972, 2973, 2974, 2975, 2979, 2980, 2981, 2982, 2983, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 2998, 2999, 3008, 3009, 3010, 3022, 3023, 3024, 3025, 3026, 3027, 3040, 3041, 3052, 3053, 3054, 3055, 3073, 3074, 3075, 3083, 3084, 3085, 3086, 3087, 3096, 3115, 3116, 3139, 3140, 3141, 3142, 3143, 3144, 3145, 3152, 3153, 3155, 3156, 3157, 3158, 3159, 3160, 3161, 3162, 3169, 3170, 3171, 3172, 3173, 3174, 3175, 3176, 3177, 3178, 3179, 3180, 3181, 3182, 3190, 3191, 3192, 3193, 3194, 3195, 3196, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3225, 3226, 3227, 3228, 3232, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3245, 3248, 3249, 3264, 3265, 3266, 3267, 3268, 3287, 3288, 3291, 3292, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3314, 3315, 3316, 3317, 3318, 3319, 3320, 3321, 3322, 3323, 3329, 3330, 3331, 3332, 3333, 3334, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3354, 3355, 3356, 3357, 3369, 3370, 3371, 3372, 3373, 3383, 3384, 3385, 3386, 3387, 3388, 3389, 3390, 3391, 3394, 3395, 3396, 3397, 3402, 3403, 3404, 3405, 3406, 3416, 3418, 3419, 3420, 3421, 3422, 3423, 3424, 3425, 3426, 3427, 3434, 3435, 3436, 3437, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3458, 3459, 3460, 3461, 3462, 3470, 3471, 3472, 3481, 3482, 3489, 3490, 3500, 3501, 3502, 3503, 3509, 3510, 3518, 3534, 3535, 3541, 3542, 3543, 3544, 3545, 3571, 3572, 3573, 3590, 3591, 3592, 3593, 3594, 3595, 3596, 3597, 3598, 3599, 3600, 3601, 3602, 3603, 3604, 3605, 3606, 3607, 3608, 3609, 3612, 3613, 3614, 3615, 3616, 3617, 3618, 3619, 3624, 3625, 3626, 3627, 3628, 3636, 3637, 3638, 3639, 3643, 3644, 3645, 3669, 3670, 3671, 3672, 3673, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3698, 3699, 3700, 3701, 3702, 3703, 3715, 3716, 3722, 3723, 3724, 3725, 3726, 3738, 3739, 3740, 3741, 3742, 3743, 3744, 3753, 3754, 3755, 3756, 3757, 3769, 3770, 3771, 3772, 3773, 3774, 3775, 3776, 3777, 3778, 3779, 3780, 3784, 3785, 3786, 3787, 3799, 3800, 3801, 3802, 3803, 3804, 3811, 3812, 3813, 3814, 3815, 3816, 3827, 3828, 3829, 3830, 3838, 3839, 3840, 3841, 3852, 3853, 3854, 3855, 3856, 3857, 3858, 3859, 3860, 3861, 3862, 3863, 3864, 3865, 3866, 3867, 3868, 3869, 3870, 3871, 3872, 3873, 3874, 3875, 3876, 3877, 3878, 3879, 3880, 3881, 3892, 3893, 3894, 3895, 3896, 3897, 3898, 3899, 3902, 3903, 3904, 3905, 3906, 3912, 3913, 3914, 3915, 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4235, 4236, 4237, 4238, 4239, 4240, 4241, 4260, 4261, 4262, 4263, 4264, 4265, 4266, 4267, 4268, 4269, 4270, 4271, 4272, 4273, 4274, 4275, 4276, 4277, 4278, 4279, 4280, 4290, 4291, 4292, 4293, 4294, 4295, 4296, 4297, 4298, 4299, 4307, 4308, 4309, 4310, 4318, 4319, 4320, 4321, 4322, 4323, 4335, 4336, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4351 and 4352.

510(k) numbers

["K972962"]

PMA numbers

not on file

Product code

DRY

Firm FEI

1828100

Firm city

Ann Arbor

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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