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	Overfill (2404)
Health Effect - Clinical Code	Increased Intra-Peritoneal Volume (IIPV) (4498)
Date of Event	01/30/2025
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
This is a report of a peritoneal dialysis (pd) patient who experienced an increased intraperitoneal volume (iipv) event coincident with pd therapy.A pd patient experienced a scale reading error message that occurred in drain 1 of 4.The biomed technician (bmt)reported that the treatment information showed there was an overfill associated with pd treatment.The overfill event was indicated due to drain 1 being 2589 ml, which is 217% of the 1194ml fill volume.As a result of the iipv event, the technical support representative advised the bmt to discontinue use of the cycler.A new cycler was issued.In a follow up, the bmt verified the overfill event and said there was no harm, intervention or adverse event due to the overfill.The cycler is available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
This is a report of a peritoneal dialysis (pd) patient who experienced an increased intraperitoneal volume (iipv) event coincident with pd therapy.A pd patient experienced a scale reading error message that occurred in drain 1 of 4.The biomed technician (bmt)reported that the treatment information showed there was an overfill associated with pd treatment.The overfill event was indicated due to drain 1 being 2589 ml, which is 217% of the 1194ml fill volume.As a result of the iipv event, the technical support representative advised the bmt to discontinue use of the cycler.A new cycler was issued.In a follow up, the bmt verified the overfill event and said there was no harm, intervention or adverse event due to the overfill.The cycler is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d.9.,h.3.Plant investigation: the actual device was returned to the manufacturer for physical analysis.A visual inspection of the returned cycler exterior showed no signs of physical damage: bezel damaged, heater tray damaged (button damaged) there were visual indications of dried fluid within the cassette compartment on the pump.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.Go/no go check ¿ passed.Load cell verification check ¿ passed.Treatment data check ¿ failed.Failure traced to: found cycler unable to hold correct treatment settings due to a faulty battery ram.Replaced battery on functional board and treatment data.Powered cycler on/off.Cycler is now able to hold correct treatment data.Due to not having the complete treatment settings' information, neither in the intake nor the cycler's memory, a long treatment was perfomed and completed with the available data.The cycler weighed fill volume values were within tolerance for a liberty cycler.Valve actuation test ¿ passed.System air leak test ¿ passed.Post-ast hours 2 hours 15 mins 8500ml simulated treatment was performed without any failures or problems.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid under the pump assembly on the bottom cover.The cause of the observed dried fluid could not be determined.There were no discrepancies encountered with the mushroom heads.The device history record did not reveal any issues or problems related to the reported symptom code(s).Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.An associated cause could not be determined.

• 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: 21382123
• Report Number: 0008030665-2025-00363
• Device Sequence Number: 8462142
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K181108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2011
• 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 Age: 80 YR
• Patient Sex: Female