190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Recall Initiated
- June 3, 2024
- Posted
- July 11, 2024
- Recall Number
- Z-2341-2024
- Quantity
- 531 units
- Firm Location
- Waltham, MA
Reason for Recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Distribution
Domestic: Nationwide Distribution. International: Canada.
Lot / Code Info
Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 4K0S192528, 4K0S192538, 4K0S192235, 4K0S192231, 4K0S192236, 4K0S192237, 2K0S180521, 2K0S180522, 2K0S180527, 3K0S186036, 3K0S182626, 3K0S182627, 3K0S182637, 3K0S182646, 3K0S184910, 3K0S185719, 3K0S185721, 3K0S185739, 3K0S185742, 3K0S186938, 3K0S186951, 3K0S186953, 3K0S186960, 3K0S186995, 3K0S186997, 4K0S190280, 4K0S191586, 4K0S191229, 4K0S191230, 4K0S191232, 4K0S191569, 4K0S191579, 4K0S191580, 4K0S192727, 4K0S192731, 2K0S179494, 2K0S179487, 3K0S182636, 4K0S192226, 4K0S192227, 4K0S192234, 4K0S192239, 4K0S192241, 4K0S192245, 3K0S186032, 3K0S184877, 3K0S184878, 3K0S184895, 3K0S185724, 3K0S185736, 3K0S186042, 3K0S186935, 3K0S186990, 4K0S190518, 4K0S190524, 4K0S191584, 4K0S192242, 4K0S192737, 3K0S182658, 4K0S191129, 4K0S191133, 4K0S192537, 4K0S192230, 2K0S180524, 2K0S180526, 3K0S185720, 2K0S180530, 2K0S180542, 4K0S190538, 4K0S191124, 3K0S184906, 4K0S191233, 3K0S185978, 3K0S186944, 2K0S181716, 3K0S182642, 3K0S185975, 2K0S180516, 3K0S186993, 2K0S179479, 2K0S180529, 2K0S180533, 2K0S179490, 3K0S182656, 3K0S184887, 3K0S182645, 3K0S182655, 2K0S179482, 2K0S179477, 3K0S182635, 3K0S185997, 3K0S186948, 3K0S184893, 4K0S191234, 1K0S172200, 2K0S179485, 1K0S171809, 4K0S191582, 1K0S171481, 3K0S182650, 3K0S186992, 3K0S182654, 3K0S185981, 3K0S186044, 1K0S172057, 4K0S191512, 3K0S185729, 3K0S185979, 3K0S182641, 3K0S182643, 3K0S184890, 4K0S192526, 4K0S192533, 4K0S192729, 4K0S192735, 1K0S171848, 1K0S172052, 3K0S185735, 3K0S184884, 3K0S184892, 1K0S171482, 4K0S191136, 4K0S191122, 4K0S191125, 4K0S191134, 4K0S191123, 4K0S191141, 4K0S192243, 4K0S192244, 4K0S192540, 4K0S190531, 3K0S184891, 3K0S185723, 3K0S185745, 3K0S185988, 3K0S186956, 3K0S187002, 1K0S171808, 4K0S190513, 3K0S185718, 4K0S190511, 4K0S190530, 3K0S182625, 2K0S181709, 2K0S181711, 3K0S186034, 3K0S186998, 3K0S186942, 1K0S172061, 1K0S171825, 1K0S171841, 1K0S171483, 1K0S171815, 2K0S179500, 2K0S181717, 3K0S186950, 3K0S185998, 3K0S184899, 4K0S192730, 4K0S190533, 3K0S185741, 3K0S186962, 4K0S190516, 3K0S185737, 3K0S185728, 4K0S192240, 4K0S192233, 3K0S185310, 2K0S180512, 2K0S180543, 4K0S190846, 3K0S185743, 1K0S172045, 3K0S184879, 3K0S184881, 3K0S184905, 3K0S186933, 2K0S179499, 2K0S179501, 2K0S181719, 3K0S187001, 3K0S186947, 3K0S185994, 3K0S185983, 1K0S172189, 3K0S184907, 3K0S185311, 3K0S184868, 3K0S186989, 3K0S186941, 4K0S192517, 1K0S171818, 4K0S191581, 1K0S171477, 1K0S171498, 2K0S181705, 4K0S192228, 1K0S171839, 1K0S171843, 3K0S186039, 4K0S191139, 4K0S191588, 1K0S171822, 1K0S171829, 2K0S181715, 3K0S182633, 3K0S182638, 3K0S186037, 4K0S190520, 2K0S180525, 2K0S180518, 3K0S185974, 1K0S171479, 3K0S184902, 1K0S171494, 3K0S184865, 3K0S184867, 3K0S184875, 3K0S184889, 3K0S185977, 3K0S185987, 3K0S185996, 3K0S182648, 2K0S181706, 1K0S172042, 3K0S185726, 3K0S186958, 4K0S192536, 3K0S185716, 4K0S192512, 4K0S192728, 1K0S171838, 2K0S181710, 3K0S185992, 4K0S190527, 4K0S190541, 2K0S180546, 3K0S186954, 3K0S182647, 3K0S184874, 3K0S185283, 4K0S190532, 4K0S190534, 3K0S182659, 1K0S171811, 1K0S171832, 1K0S171844, 3K0S186996, 3K0S186999, 3K0S185725, 3K0S185727, 3K0S185982, 4K0S190844, 4K0S190526, 4K0S191570, 1K0S171492, 3K0S186952, 1K0S171491, 3K0S182634, 2K0S181708, 3K0S186991, 3K0S186040, 3K0S185717, 1K0S172192, 2K0S179495, 3K0S182644, 4K0S190539, 4K0S190845, 4K0S190847, 4K0S192527, 1K0S172049, 3K0S182632, 3K0S182651, 3K0S186041, 2K0S179496, 3K0S186939, 4K0S192734, 3K0S185995, 4K0S191140, 3K0S184911, 1K0S172182, 4K0S191131, 4K0S191135, 2K0S181713, 4K0S191130, 3K0S184908, 4K0S192229, 4K0S190522, 1K0S172185, 4K0S192530, 2K0S180517, 2K0S180531, 4K0S190852, 4K0S190853, 2K0S179488, 4K0S191231, 3K0S184894, 2K0S179484, 3K0S182652, 3K0S182657, 4K0S192516, 4K0S190543, 1K0S172059, 1K0S172190, 3K0S184872, 3K0S182629, 3K0S185985, 3K0S186946, 4K0S190512, 1K0S172186, 1K0S172188, 1K0S171810, 1K0S171831, 1K0S171828, 1K0S171842, 3K0S185284, 3K0S185309, 3K0S185722, 3K0S184903, 4K0S190850, 3K0S185281, 3K0S186043, 3K0S184864, 1K0S171480, 3K0S182649, 3K0S185984, 4K0S190521, 4K0S190528, 4K0S190535, 4K0S190536, 4K0S190542, 4K0S192519, 4K0S192525, 4K0S192531, 1K0S172043, 1K0S172193, 2K0S179478, 2K0S179481, 4K0S191585, 4K0S192238, 4K0S192515, 4K0S192524, 3K0S182628, 2K0S179497, 3K0S182630, 3K0S186934, 1K0S171485, 3K0S185733, 3K0S186035, 4K0S192732, 3K0S185731, 1K0S171476, 1K0S172051, 3K0S182653, 3K0S182639, 4K0S192724, 4K0S192726, 1K0S171814, 4K0S190523, 4K0S190854, 4K0S190510, 4K0S191126, 4K0S191127, 1K0S171497, 3K0S182631, 1K0S171827, 3K0S184909, 1K0S171824, 1K0S171826, 1K0S171475, 1K0S171499, 2K0S179480, 2K0S179483, 2K0S180513, 2K0S180519, 3K0S186945, 3K0S186957, 3K0S186936, 3K0S186045, 2K0S181707, 2K0S181712, 2K0S181718, 1K0S171487, 3K0S186940, 3K0S186959, 3K0S185986, 3K0S185991, 4K0S190540, 2K0S180520, 2K0S180532, 2K0S180628, 4K0S190851, 4K0S191587, 3K0S185282, 3K0S186031, 2K0S181714, 3K0S184869, 3K0S184871, 3K0S184873, 3K0S184880, 3K0S184900, 3K0S184904, 3K0S184912, 3K0S184866, 3K0S184876, 3K0S184886, 3K0S184888, 3K0S184896, 3K0S184897, 3K0S184898, 3K0S185993, 3K0S186033, 4K0S192513, 4K0S192535, 4K0S191572, 4K0S190529, 1K0S171833, 1K0S171840, 3K0S185308, 1K0S171849, 1K0S172044, 4K0S192725, 4K0S192529, 2K0S180523, 4K0S191137, 3K0S186937, 3K0S186943, 3K0S186994, 1K0S172196, 1K0S172264, 1K0S172265, 1K0S172183, 1K0S172263, 1K0S171837, 1K0S171493, 1K0S172191, 1K0S172201, 1K0S171489, 1K0S171807, 1K0S172054, 1K0S172194, 1K0S172198, 1K0S171820, 1K0S172205, 1K0S171819, 1K0S171830, 1K0S171486, 1K0S171836, 2K0S179486, 2K0S179492, 2K0S179493, 2K0S179498, 1K0S171812, 1K0S171813, 1K0S171821, 1K0S172048, 1K0S172053, 1K0S172060, 1K0S172179, 1K0S172184, 1K0S172204, 1K0S171847, 1K0S172180, 1K0S172203, 1K0S172195, 1K0S172197, 1K0S171816, 1K0S171835, 1K0S172058, 1K0S172187, 1K0S172199, 3K0S184882, 3K0S184901, 3K0S184883, 3K0S185307, 3K0S185976, 4K0S191138, 4K0S190848, 4K0S191128, 4K0S192521, 3K0S182640, 1K0S171817, 3K0S185980, 3K0S186961, 3K0S186949, 4K0S191513, 1K0S171834, 2K0S179491, 4K0S192733, 4K0S192723.
Root Cause
Component design/selection
Action Taken
On June 3, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to consignees. Fresenius Medical Care is requesting replacement of affected Blood Pump Rotors in 2008K@HOME systems due to the patients possibly being unaware of this component failing. To order for a replacement Blood Pump Rotor (Part Number, F40015481), contact Fresenius Medical Care Customer Service at 800-227-2572, OPTION 3, o Please have Blood Pump Rotor Part Number and Lot Number available when requesting a replacement. CUSTOMER: 1. Please provide this letter to your Biomedical Technician. 2. Report any complaints or adverse events to product.complaints@fmc-na.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. 3. Provide this Customer Notice to all those who need to be aware within your organization. 4. Complete and return the attached reply form. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.