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	07/01/2025
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 nurse (pdrn) discovered a fluid leak on the inside of the cassette door of the clinic cycler after ending a patient¿s pd treatment.It was reported that the supplies were connected correctly and fluid was discovered on the back of the cassette.Fluid was not discovered in the pump module area.Fluid leaked from a small hole on the back of the cassette.The cause of the leak is unknown.Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.Stated that the patient was prescribed prophylactic antibiotics.Confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The cycler set used is available for return for physical evaluation by the manufacturer.
Event or Problem Description
It was reported that a peritoneal dialysis nurse (pdrn) discovered a fluid leak on the inside of the cassette door of the clinic cycler after ending a patient¿s pd treatment.It was reported that the supplies were connected correctly and fluid was discovered on the back of the cassette.Fluid was not discovered in the pump module area.Fluid leaked from a small hole on the back of the cassette.The cause of the leak is unknown.Upon follow up, the pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.Stated that the patient was prescribed prophylactic antibiotics.Confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The cycler set used is available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Additional information provided in d9 and h3.Plant investigation: the product sample was received for evaluation, the sample was received open with different package.A disinfection was performed to the complaint product sample.As the complaint product sample was being disinfected according to and prepared for analysis the alleged failure mode was confirmed: a leak was found in the cassette film.The complaint product simple was visually inspected and during the visual inspection with the microscope a hole was found in the cassette film, no damages were found in the cassette hard plastic.This kind of damage could have the following causes: pump door is sharp per closes unexpectedly during set up, stress and strain on the film during teach pump when mushroom head is fully extended against the cassette dome, especially with a large misalignment between cassette and pump, finishing problem due to a sharp point created or cassette damaged mechanically, shipping or transportation damages the product.A device history record review was performed for the involved lot of the product and there were no non-conformances, or any associated rework related with the alleged failure mode during the assembly process of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.The event was confirmed based on the sample evaluation; the returned sample was scrapped after evaluation.

• 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: 22441258
• Report Number: 0008030665-2025-01547
• Device Sequence Number: 15321874
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/06/2026

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: Health Professional
• Device Catalogue Number: 050-87215A
• Device Lot Number: 24ER08087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 63 KG