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	07/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male peritoneal dialysis (pd) patient was diagnosed with peritonitis.The patient transitioned to in-center hemodialysis.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was initially diagnosed with peritonitis on (b)(6) 2026.The patient was experiencing abdominal pain and cloudy pd fluid.The patient went to the emergency room (er) to have cultures drawn.The patient was diagnosed with peritonitis and subsequently admitted to the hospital.The patient was initially started on antibiotic therapy with intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown).The culture results were not received from the hospital, but the physician documented them as positive for acinetobacter (no species).The patient¿s antibiotics were changed to gentamicin (dose, frequency, and duration unknown).The patient was discharged on (b)(6) 2026 and they completed the antibiotic regimen.The patient was then seen at the pd clinic on (b)(6) 2026 due to cloudy pd fluid.The patient had pd cultures obtained.The patient was started on antibiotic therapy with intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown).The patient¿s culture resulted positive for acinetobacter ursingii.On (b)(6) 2026 the patient was admitted to the hospital due to no improvement with symptoms.The patient¿s pd catheter was removed (unknown date).The patient transitioned to hemodialysis (hd).It is unknown if the patient will return to pd therapy after recovery.The patient was administered intravenous (iv) antibiotics during the hospitalization (drug, dose, frequency, and duration unknown).The patient was discharged on (b)(6) 2026 and is completing in-center hd.The cause of the peritonitis event was not determined.It is suspected that it could be the patient¿s shower head or something in the environment at the patient¿s construction job.This is considered relapsing peritonitis as this was a new episode of peritoneal infection that occurred within 4 weeks of completing antibiotics caused by the same organism (acinetobacter).
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical investigation: there is a temporal relationship between peritoneal dialysis and utilization of the liberty select cycler and liberty cycler set and the patient event of relapsing peritonitis with hospitalization.However, there is no documentation in the complaint file to show a causal relationship between the adverse 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 a definitive cause of the relapsing peritonitis was not determined, the culture result of acinetobacter suggests a lack of aseptic technique or a touch contamination event.This genus is broadly distributed in nature as a saprophytic bacteria in soil, sewage, water, skin, the gastrointestinal tract and the hospital environment.This organism is also known to have an ¿inherent ability to develop antibiotic resistance.This could account for the relapsing peritonitis.Based on the available information and no allegation or evidence of a 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: 50883111
• Report Number: 0008030665-2026-02563
• Device Sequence Number: 16141103
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/24/2026

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: 09/17/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male