MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE PATIENT CONN; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient¿s peritoneal dialysis nurse (pdrn) that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.A balloon valve leak alarm occurred during fill 1 of 1 of treatment and the treatment was cancelled.The cycler was reset up with new supplies.Fluid was discovered in the pump module area and on the external of the cassette.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler.A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the pdrn noted that the location of the leak was directly from the cassette, dropping out the bottom of the door onto the floor below the cycler.All connected correctly as the pdrn set up the cycler.The patient was not able to use the cycler overnight for dialysis, it was supposed to be the first treatment at home for him and he was very concerned that a brand new machine was broken on arrival.The patient had to do manual exchanges, but the patient is still in training, it was the very first time at home using the cycler and now they are instead doing backup manuals.The patient couldn't complete a treatment as the cycler was broken and he is still in training thus not able to get all the manual exchanges he needed.The patient is symptomatically uremic and this created a large setback in managing his symptoms.There was no breach in infection control or concern of infection related to the event.It is confirmed that the patient has received the replacement cycler and continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.Confirmed that the cycler set was available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Additional information provided in d9 and h3.Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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.
Event or Problem Description
It was reported by the patient¿s peritoneal dialysis nurse (pdrn) that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.A balloon valve leak alarm occurred during fill 1 of 1 of treatment and the treatment was cancelled.The cycler was reset up with new supplies.Fluid was discovered in the pump module area and on the external of the cassette.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler.A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the pdrn noted that the location of the leak was directly from the cassette, dropping out the bottom of the door onto the floor below the cycler.All connected correctly as the pdrn set up the cycler.The patient was not able to use the cycler overnight for dialysis, it was supposed to be the first treatment at home for him and he was very concerned that a brand new machine was broken on arrival.The patient had to do manual exchanges, but the patient is still in training, it was the very first time at home using the cycler and now they are instead doing backup manuals.The patient couldn't complete a treatment as the cycler was broken and he is still in training thus not able to get all the manual exchanges he needed.The patient is symptomatically uremic and this created a large setback in managing his symptoms.There was no breach in infection control or concern of infection related to the event.It is confirmed that the patient has received the replacement cycler and continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.Confirmed that the cycler set was available to be returned to the manufacturer for physical 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: 21752416
• Report Number: 0008030665-2025-00742
• Device Sequence Number: 9700987
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/10/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 050-87215
• Device Lot Number: 23DR08121
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 65 KG