MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY SELECT CYCLER ASSY(NON-VALUATED); System, Peritoneal, Automatic Delivery

Catalog Number	RTLR180343
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported to fresenius medical care (fme) technical support (ts) on (b)(6) 2026 that there was a burning smell coming from the cycler.The pdrn will not use this cycler and is requesting a replacement.At that point in time, the technical support representative advised the pdrn to discontinue using the cycler and a replacement cycler was issued due to the burning smell.Additional information was requested, however to date has not been provided.The cycler was returned to the manufacturer, and a replacement cycler was provided.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.
Additional Manufacturer Narrative
Plant investigation: a visual inspection of the returned cycler exterior showed no signs of physical damage.There were no visual indications of dried fluid within the cassette compartment.There were visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.Touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel display remained dim.An internal inspection of the cycler found a short on t1 of the inverter board with lot code¿1904 which reflects the transformer has "[p155]" insulation thickness.¿the inverter board is located on the rear of the front panel assembly.¿a¿known good¿inverter board was¿installed¿and the display became operational.¿touch screen test passed.Voltage check test passed.System air leak test passed.Valve actuation test passed.Post-ast 2hr 15mins 8500ml simulated treatment was performed without any failures or problems.There were no visual discrepancies encountered during the internal inspection.The device history record did not reveal any issues or problems related to the reported symptom code(s).The actual device was returned to the manufacturer for physical evaluation.Upon completion of the evaluation, the reported issue was confirmed, and the cause was determined to be an internal short on transformer on the inverter board.The cycler was refurbished following the evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Common Device Name: System, Peritoneal, Automatic Delivery
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50870267
• Report Number: 0008030665-2026-02549
• Device Sequence Number: 21498089
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Delflex PD Fluid.; Liberty Cycler Set.
• Patient Sex: Unknown