—#208255

Product

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032, 7K0S300031, 7K0S300059, 7K0S300017, 7K0S300066, 6K0S163669, 5K0S193667, 5K0S193669, 5K0S193670, 5K0S193672, 5K0S193674, 5K0S193675, 5K0S194147, 5K0S194152, 5K0S194154, 5K0S194177, 6K0S169444, 6K0S172007, 6K0S165410, 6K0S167031, 6K0S171195, 6K0S171197, 6K0S171209, 5K0S194180, 7K0S300024, 5K0S193169, 6K0S169447, 6K0S169440, 6K0S172012, 6K0S172017, 6K0S159418, 6K0S169462, 6K0S167042, 7K0S300053, 6K0S167040, 6K0S167041, 4K0S190313, 5K0S194158, 6K0S171201, 6K0S169436, 5K0S193315, 7K0S300014, 6K0S162835, 6K0S162836, 6K0S167034, 6K0S167052, 7K0S300091, 6K0S159428, 5K0S194153, 5K0S193336, 6K0S169438, 6K0S169450, 7K0S300043, 5K0S194160, 7K0S300071, 7K0S300005, 6K0S172011, 6K0S169452, 6K0S172005, 5K0S193144, 7K0S300058, 5K0S193328, 6K0S159421, 5K0S194163, 6K0S169449, 6K0S169453, 6K0S171204, 7K0S300010, 7K0S300089, 6K0S163668, 6K0S159424, 6K0S159431, 6K0S167037, 5K0S193665, 7K0S300028, 5K0S193160, 6K0S167039, 7K0S300093, 7K0S300095, 6K0S163674, 7K0S300022, 5K0S193163, 5K0S194148, 6K0S172018, 6K0S165414, 6K0S163672, 6K0S163681, 6K0S163676, 6K0S163680, 6K0S169437, 7K0S300035, 5K0S193152, 6K0S159420, 6K0S169439, 6K0S169464, 6K0S171198, 6K0S171206, 6K0S171999, 6K0S172016, 6K0S172020, 6K0S169457, 6K0S172002, 6K0S172013, 6K0S162833, 6K0S165411, 6K0S165413, 7K0S300102, 7K0S300033, 5K0S194150, 6K0S162832, 6K0S169445, 5K0S193168, 5K0S194149, 6K0S163682, 6K0S162839, 6K0S167047, 6K0S171196, 5K0S194157, 5K0S193334, 7K0S300103, 6K0S169434, 6K0S162831, 6K0S163673, 6K0S172014, 6K0S163675, 6K0S163685, 7K0S300021, 6K0S163666, 5K0S193154, 5K0S193325, 6K0S165408, 5K0S193143, 5K0S193158, 5K0S194168, 7K0S300078, 5K0S193149, 5K0S193157, 5K0S193170, 7K0S300030, 5K0S193323, 5K0S193331, 7K0S300107, 6K0S159419, 6K0S159426, 6K0S169456, 7K0S300087, 7K0S300075, 5K0S194151, 6K0S163686, 7K0S300029, 5K0S193156, 5K0S193164, 6K0S169460, 6K0S167043, 6K0S167048, 6K0S167050, 6K0S169465, 7K0S300070, 7K0S300068, 6K0S167053, 6K0S167033, 6K0S167055, 6K0S167032, 5K0S193171, 5K0S193172, 6K0S169443, 6K0S167046, 7K0S300042, 5K0S194171, 4K0S190319, 5K0S193330, 5K0S193153, 5K0S193671, 5K0S194175, 6K0S169466, 6K0S169467, 6K0S171995, 6K0S172003, 6K0S169461, 6K0S171202, 6K0S171210, 6K0S171199, 6K0S171207, 6K0S171211, 6K0S172009, 5K0S193333, 6K0S163667, 6K0S163671, 6K0S172015, 6K0S171996, 6K0S171997, 5K0S193316, 6K0S163679, 6K0S172000, 7K0S300072, 7K0S300100, 7K0S300008, 7K0S300020, 7K0S300026, 6K0S171998, 5K0S193335, 5K0S194165, 6K0S162827, 6K0S162828, 6K0S162838, 6K0S162843, 5K0S193329, 5K0S193148, 5K0S193145, 5K0S193150, 6K0S162841, 5K0S193668, 6K0S159416, 6K0S162846, 6K0S167038, 5K0S194170, 4K0S190309, 5K0S193155, 5K0S193679, 5K0S194155, 6K0S169454, 6K0S169463, 6K0S159422, 6K0S159425, 6K0S169435, 6K0S167054, 6K0S172006, 6K0S172024, 6K0S171208, 6K0S172004, 6K0S169451, 6K0S163678, 7K0S300047, 7K0S300051, 7K0S300054, 7K0S300064, 7K0S300065, 7K0S300076, 7K0S300098, 6K0S169459, 6K0S167036, 6K0S169455, 5K0S193321, 5K0S193666, 5K0S193673, 7K0S300106, 7K0S300104, 6K0S167030, 7K0S300041, 7K0S300050, 7K0S300052, 7K0S300057, 7K0S300090.

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Domestic: Nationwide Distribution. International: Canada.

Timeline

Recall initiated: 2024-06-03
Posted by FDA: 2024-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.