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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient contact discovered a fluid leak during dwell 2 of 4 of their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 2 of 4 of treatment and the treatment was cancelled.Fluid was seen underneath the cycler cart.Fluid was not discovered in the pump module area or on the external of the cassette.The cause of the leak is unknown.The patient contact does not see any rips or tears in the heater bag (hb).Upon follow up, the patient contact confirmed the reported event.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using new supplies with the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set is 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: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.The samples were received open with different package.As the complaint product sample was being disinfected and prepared for analysis, no leaks or damage in the cassette were observed.The cassette set was in the expected condition.The complaint product sample was visually inspected according to bom 050-87215, during the inspection no problems were found, no damages in the lines nor the cassette were observed.The cassette set was in the expected condition.A functional test was performed to the complaint product samples with the cycler machine.During functional test (drain 5/5) air bubbles were found in the lines.No alarms, leaks or other issues were detected, after completed the test the cassette was removed from cycler and no moisture were found.The test was completed successfully.A device history record (dhr) review was performed for the involved lot of the product and there were no non-conformances, deviations 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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient contact discovered a fluid leak during dwell 2 of 4 of their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 2 of 4 of treatment and the treatment was cancelled.Fluid was seen underneath the cycler cart.Fluid was not discovered in the pump module area or on the external of the cassette.The cause of the leak is unknown.The patient contact does not see any rips or tears in the heater bag (hb).Upon follow up, the patient contact confirmed the reported event.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient was able to complete peritoneal dialysis treatment using new supplies with the cycler.The patient contact confirmed that the patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the cycler set is 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: 19670370
• Report Number: 0008030665-2024-00580
• Device Sequence Number: 19624594
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 050-87215
• Device Lot Number: 23PR08038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 73 KG