MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	RTLR180111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
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 registered nurse (pdrn) discovered a fluid leak from an unknown location after ending the patient's pd treatment.The pdrn reported receiving alarms prior to the leak but does not recall which alarms.Fluid was discovered in the pump module area and 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 pdrn was advised to use the cycler for next day's treatment and to call if issues continue.Upon follow up, the pdrn confirmed the reported event and that 17 alarms were received prior to the leak.The pdrn stated not knowing which alarms were present and could not confirm the location of the fluid leak.The pdrn stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient was able to complete peritoneal dialysis treatment using a different cycler.The pdrn confirmed that the other cycler is performing without reoccurrence of the reported event.The pdrn confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a fluid leak from an unknown location after ending the patient's pd treatment.The pdrn reported receiving alarms prior to the leak but does not recall which alarms.Fluid was discovered in the pump module area and 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 pdrn was advised to use the cycler for next day's treatment and to call if issues continue.Upon follow up, the pdrn confirmed the reported event and that 17 alarms were received prior to the leak.The pdrn stated not knowing which alarms were present and could not confirm the location of the fluid leak.The pdrn stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient was able to complete peritoneal dialysis treatment using a different cycler.The pdrn confirmed that the other cycler is performing without reoccurrence of the reported event.The pdrn confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(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 ; 6174175172
• MDR Report Key: 22534496
• Report Number: 0008030665-2025-01625
• Device Sequence Number: 17994573
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123630
• 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): 11/25/2025

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: RTLR180111
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Sex: Unknown