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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This female peritoneal dialysis (pd) patient reported they have peritonitis.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was seen in the pd clinic on (b)(6) 2026 due to cloudy pd effluent and abdominal pain.The patient had pd cultures drawn.The patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy with intraperitoneal (ip) ceftazidime 1g daily for 21 days.The culture resulted positive for klebsiella pneumoniae.The patient did not require hospitalization.The cause of the peritonitis event is undetermined.The patient denies any break in sterile technique.No report of a cassette or solution leak was reported.The patient continues to complete pd therapy during recovery.
Additional Manufacturer Narrative
Clinical investigation: there is a temporal relationship between peritoneal dialysis and the utilization of the liberty select cycler with liberty cycler set and the patient event of peritonitis.However, there is no documentation to show a causal relationship between the peritonitis event and use of the liberty select cycler and liberty cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.Although no information was provided related to the cause of peritonitis, the culture resulted positive for klebsiella pneumoniae.This organism is part of the normal flora of the gi tract, may colonize the upper aerodigestive tract and gu tract, and are widespread in the environment.Peritonitis probably results from touch contamination, but sometimes from an exit-site or tunnel infection or from an intra-abdominal source.Based on the available information and no allegations or evidence of malfunction, deficiency, or defect, the liberty select cycler and liberty cycler set can be excluded as the cause of the patient¿s peritonitis event.

• 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: 50927094
• Report Number: 0008030665-2026-02591
• Device Sequence Number: 10735204
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/21/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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 Select Cycler.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female