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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the tubing after ending their pd treatment.The patient opened the cassette door and noticed fluid leaking from the lines but did not see where it came from.The patient reported not receiving an alarm prior to the leak.Fluid was not discovered in the pump module area or on the external of the cassette.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The cycler set has been discarded since this occurred in the morning when the patient was removing the supplies.The patient wanted to know if it's safe to continue using the cycler since no physical fluid was found inside the cassette compartment.The patient was advised to continue the use of their cycler.Upon follow up, the pdrn stated they have not been made aware of the event, however, confirmed the patient has not reported development of any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn verified per treatment data that the patient completed treatment using the cycler and new supplies.The patient has been performing subsequent treatments using the cycler with no further issues.
Additional Manufacturer Narrative
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) patient discovered a fluid leak on the tubing after ending their pd treatment.The patient opened the cassette door and noticed fluid leaking from the lines but did not see where it came from.The patient reported not receiving an alarm prior to the leak.Fluid was not discovered in the pump module area or on the external of the cassette.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The cycler set has been discarded since this occurred in the morning when the patient was removing the supplies.The patient wanted to know if it's safe to continue using the cycler since no physical fluid was found inside the cassette compartment.The patient was advised to continue the use of their cycler.Upon follow up, the pdrn stated they have not been made aware of the event, however, confirmed the patient has not reported development of any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn verified per treatment data that the patient completed treatment using the cycler and new supplies.The patient has been performing subsequent treatments using the cycler with no further issues.
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.The entire set of lots have been sold and distributed.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.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause 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 ; 6174175172
• MDR Report Key: 23513183
• Report Number: 0008030665-2025-02701
• Device Sequence Number: 9733307
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 050-87215A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/11/2026
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Female