MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; System, Peritoneal, Automatic Delivery

Catalog Number	050-87212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peritonitis (2252); Unspecified Heart Problem (4454)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported on that this peritoneal dialysis (pd) patient went into the hospital a few weeks prior with cardiac issues (unspecified).When the pdrn followed up, the patient had been diagnosed with peritonitis.Attempts to obtain additional information were unsuccessful.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a possible temporal relationship between peritoneal dialysis utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis.However, it is unknown whether the peritonitis was diagnosed upon admission to the hospital or after the patient had already been hospitalized.It is unknown if the patient was utilizing fresenius medical care products during the hospitalization.There is no documentation of a causal relationship between the use of the liberty select cycler with liberty cycler set and the patient event of peritonitis.Additionally, there was no allegation or evidence of a device malfunction or deficiency, or cycler set defect reported for this event.Although no information was provided related to culture results or the determined cause of the reported peritonitis, all pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.Based on limited information and no allegation of a malfunction, deficiency, or defect, and not knowing if the patient was utilizing any fresenius medical care products at the time of the event, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s reported peritonitis event.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 50524486
• Report Number: 0008030665-2026-02336
• Device Sequence Number: 13302843
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 050-87212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Delflex PD Fluid; Liberty Select Cycler
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown