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	Overfill (2404)
Health Effect - Clinical Code	Increased Intra-Peritoneal Volume (IIPV) (4498)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient (pt) reported to fresenius medical care (fme) technical service (ts) on(b)(6)2026 that fill complication encountered message occurred in fill 1 of 5 and the patient was connected during the incident.The patient experienced an increased intraperitoneal volume (iipv) event coincident with their peritoneal dialysis (pd) therapy on (b)(6)2026.The event was discovered while reviewing the patient¿s treatment records.A review of the patient¿s treatment records identified that the patient drained (b)(6) during drain 4 of the treatment.This drain volume for drain 4 is (b)(6) of the patient's prescribed fill volume of (b)(6).As a result of the iipv event, the technical support representative advised replacing the cycler due to the iipv being over (b)(6), but patient declined stating that they do not believe it's the cycler.Pt believes the issue is the catheter, and they are working along the dr to figure out what is causing the pt to have notice draining slowly message throughout the night and at a daily basis.Pt will continue with the tx.Upon follow-up conducted on (b)(6)2026, the patient confirmed the reported event.The patient confirmed they did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient confirmed treatment was completed using the cycler on the night of the reported event.The patient advised that the issue might be the pd catheter and not the cycler.The patient stated that they are scheduled to have the catheter re-assed for placement/positioning.Per the patient the peritoneal dialysis registered nurse (pdrn) is aware of the drainage issue and the cycler alarm.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 50863432
• Report Number: 0008030665-2026-02534
• Device Sequence Number: 13089735
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2010
• 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: Male