Device product
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Z-1059-2019
Product summary
- Firm
- Fenwal Inc
- Event
- Event 82194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 198 devices
- Official record key
device-enforcement:Z-1059-2019
Official wording
Reason: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Code information: Material Number 9005851; Serial Numbers: 5VTA0180, 5VTA0183, 5VTA0194, 5VTA0195, 5VTA0196, 5VTA0197, 5VTA0198, 5VTA0199, 5VTA0200, 5VTA0201, 5VTA0202, 5VTA0203, 5VTA0204, 5VTA0205, 5VTA0206, 5VTA0234, 5VTA0235, 5VTA0236, 5VTA0237, 5VTA0238, 5VTA0239, 5VTA0240, 5VTA0241, 5VTA0242, 5VTA0243, 5VTA0244, 5VTA0245, 5VTA0246, 5VTA0247, 5VTA0248, 5VTA0249, 5VTA0250, 5VTA0251, 5VTA0252, 5VTA0253, 5VTA0254, 5VTA0255, 5VTA0256, 6VTA0257, 6VTA0258, 6VTA0259, 6VTA0260, 6VTA0261, 6VTA0262, 6VTA0263, 6VTA0264, 6VTA0265, 6VTA0266, 6VTA0289, 6VTA0295, 6VTA0296, 6VTA0297, 6VTA0298, 6VTA0299, 6VTA0300, 6VTA0301, 6VTA0302, 6VTA0303, 6VTA0304, 6VTA0305, 6VTA0337, 6VTA0338, 6VTA0339, 6VTA0340, 6VTA0341, 6VTA0342, 6VTA0343, 6VTA0344, 6VTA0430, 6VTA0431, 6VTA0432, 6VTA0433, 6VTA0434, 6VTA0435, 6VTA0436, 6VTA0437, 6VTA0438, 6VTA0439, 6VTA0440, 6VTA0441, 6VTA0442, 6VTA0443, 6VTA0444, 6VTA0445, 6VTA0450, 6VTA0451, 6VTA0452, 6VTA0453, 6VTA0454, 6VTA0455, 6VTA0456, 6VTA0457, 7VTA0458, 7VTA0459, 7VTA0460, 7VTA0461, 7VTA0463, 7VTA0464, 7VTA0465, 7VTA0466, 7VTA0467, 7VTA0468, 7VTA0469, 7VTA0470, 7VTA0471, 7VTA0472, 7VTA0473, 7VTA0474, 7VTA0475, 7VTA0476, 7VTA0477, 7VTA0478, 7VTA0479, 7VTA0480, 7VTA0481, 7VTA0482, 7VTA0483, 7VTA0484, 7VTA0485, 7VTA0486, 7VTA0487, 7VTA0488, 7VTA0489, 7VTA0490, 7VTA0491, 7VTA0492, 7VTA0493, 7VTA0494, 7VTA0495, 7VTA0496, 7VTA0497, 7VTA0525, 7VTA0526, 7VTA0527, 7VTA0528, 7VTA0529, 7VTA0530, 7VTA0531, 7VTA0532, 7VTA0533, 7VTA0534, 7VTA0535, 7VTA0536, 7VTA0537, 7VTA0538, 7VTA0539, 7VTA0540, 7VTA0541, 7VTA0542, 7VTA0543, 7VTA0544, 7VTA0545, 7VTA0553, 7VTA0554, 7VTA0555, 7VTA0558, 7VTA0559, 7VTA0560, 7VTA0575, 7VTA0582, 7VTA0583, 7VTA0584, 7VTA0585, 7VTA0586, 7VTA0587, 7VTA0588, 7VTA0589, 7VTA0590, 7VTA0591, 7VTA0592, 7VTA0593, 7VTA0594, 7VTA0595, 7VTA0596, 7VTA0597, 7VTA0598, 7VTA0599, 7VTA0606, 7VTA0607, 7VTA0608, 7VTA0609, 7VTA0610, 7VTA0611, 7VTA0612, 7VTA0613, 7VTA0614, 7VTA0616, 7VTA0617, 7VTA0618, 7VTA0620, 7VTA0672, 7VTA0673, 7VTA0674, 7VTA0675, 7VTA0676, 7VTA0677, 7VTA0678, 7VTA0679, 7VTA0680, 7VTA0681, 7VTA0683, 7VTA0684, 7VTA0685, 7VTA0686, 7VTA0687, 7VTA0688, 7VTA0689, 7VTA0690, 7VTA0691, 7VTA0692, 7VTA0693, 7VTA0694, 7VTA0695, 7VTA0696, 7VTA0697, 7VTA0698, 7VTA0699, 7VTA0700, 7VTA0701, 7VTA0702, 7VTA0708, 7VTA0709, 7VTA0710, 7VTA0711, 7VTA0712, 7VTA0713, 7VTA0714, 7VTA0715, 7VTA0716, 7VTA0717, 7VTA0718, 7VTA0719, 7VTA0720, 7VTA0721, 7VTA0722, 7VTA0723, 7VTA0724, 7VTA0725, 7VTA0729, 7VTA0759, 7VTA0760, 7VTA0761, 7VTA0762, 7VTA0763, 7VTA0764, 7VTA0765, 7VTA0766, 7VTA0767, 7VTA0768, 7VTA0769, 7VTA0770, 7VTA0771, 7VTA0772, 7VTA0773, 7VTA0774, 7VTA0775, 7VTA0776, 7VTA0777, 7VTA0778, 7VTA0779, 7VTA0780, 7VTA0781, 7VTA0806, 7VTA0807, 7VTA0858, 7VTA0859, 7VTA0860, 7VTA0861, 7VTA0862, 7VTA0863, 7VTA0864, 7VTA0865, 7VTA0866, 7VTA0867, 7VTA0868, 7VTA0869, 7VTA0870, 7VTA0871, 7VTA0872, 7VTA0873, 7VTA0874, 7VTA0875, 7VTA0876, 7VTA0877, 7VTA0878, 7VTA0879, 7VTA0880, 7VTA0881, 7VTA0898, 7VTA0901, 7VTA0902, 7VTA0903, 7VTA0904, 7VTA0905, 7VTA0906, 7VTA0907, 8VTA0908, 8VTA0909, 8VTA0910, 8VTA0911, 8VTA0912, 8VTA0913, 8VTA0914, 8VTA0915, 8VTA0916, 8VTA0917, 8VTA0918, 8VTA0919, 8VTA0920, 8VTA0921, 8VTA0922, 8VTA0923, 8VTA0924, 8VTA0925, 8VTA0926, 8VTA0937, 8VTA0938, 8VTA0939, 8VTA0940, 8VTA0941, 8VTA0942, 8VTA0943, 8VTA0944, 8VTA0945, 8VTA0946, 8VTA0947, 8VTA0948, 8VTA0949, 8VTA0950, 8VTA0951, 8VTA0952, 8VTA0953, 8VTA0954, 8VTA0955, 8VTA0956, 8VTA0957.
Distribution pattern: US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.
Derived failure modes
-
Unknown
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.