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

Catalog Number	050-87215A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peritonitis (2252); Peritoneal effluent abnormal (4904)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.However, currently there is no objective evidence that a liberty cycler set malfunction or product deficiency caused this event.Peritonitis is a well-documented complication in pd patients.Based on the reported information, peritonitis can be reasonably attributed to patient breach in aseptic technique.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) was diagnosed with peritonitis.Per the pd nurse, on (b)(6) 2026 the patient was seen in the outpatient pd clinic with symptoms of cloudy pd effluent.As a result, the patient had a pd culture obtained (the same day) which was positive for growth of the bacteria klebsiella (species not provided).The patient was initiated on intra-peritoneal (ip) antibiotic therapy utilizing cefepime (dose not provided).The patient continued pd with the same cycler, per nurse.The patient¿s nurse confirmed that the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis event.The nurse indicated the peritonitis was due to patient breach in aseptic technique.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) was diagnosed with peritonitis.Per the pd nurse, on (b)(6) 2026 the patient was seen in the outpatient pd clinic with symptoms of cloudy pd effluent.As a result, the patient had a pd culture obtained (the same day) which was positive for growth of the bacteria klebsiella (species not provided).The patient was initiated on intra-peritoneal (ip) antibiotic therapy utilizing cefepime (dose not provided).The patient continued pd with the same cycler, per nurse.The patient¿s nurse confirmed that the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis event.The nurse indicated the peritonitis was due to patient breach in aseptic technique.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.No sample has been provided at this time.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.A review of the user guide was performed.The user guide states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.As the complaint sample was not available a physical evaluation could not be performed, therefore the alleged event could not be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• 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: 25753677
• Report Number: 0008030665-2026-01698
• Device Sequence Number: 13368791
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-87215A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male