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	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient experienced a fluid leak from the heater bag (hb) during dwell 4 of 4 of treatment.An air detected in cassette alarm occurred several times during dwell 4 of 4 prior to the leak.The patient stated the hb was securely connected but when the hb was lifted up there was a puddle of fluid on the heater tray (ht).There were no holes found in the hb.The patient was advised to follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the patient confirmed the reported event and that fluid had leaked onto the floor.The patient confirmed that the fluid was not condensation.The patient checked the connection to the cycler set with a patient contact and both found the connection to be secured properly.There was no fluid or moisture found within the cycler door.The patient could not confirm where the fluid leak originated from.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient could not perform the last fill and bypassed to perform a stat drain in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event after working with the pdrn to bypass drain 0.The patient confirmed that the cycler set and solution bag were discarded and not available to be returned to the manufacturers 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
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 that a peritoneal dialysis (pd) patient experienced a fluid leak from the heater bag (hb) during dwell 4 of 4 of treatment.An air detected in cassette alarm occurred several times during dwell 4 of 4 prior to the leak.The patient stated the hb was securely connected but when the hb was lifted up there was a puddle of fluid on the heater tray (ht).There were no holes found in the hb.The patient was advised to follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the patient confirmed the reported event and that fluid had leaked onto the floor.The patient confirmed that the fluid was not condensation.The patient checked the connection to the cycler set with a patient contact and both found the connection to be secured properly.There was no fluid or moisture found within the cycler door.The patient could not confirm where the fluid leak originated from.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient could not perform the last fill and bypassed to perform a stat drain in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event after working with the pdrn to bypass drain 0.The patient confirmed that the cycler set and solution bag were discarded and not available to be returned to the manufacturers 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: 21234978
• Report Number: 0008030665-2025-00202
• Device Sequence Number: 15505553
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/28/2025

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: 050-87215A
• Device Lot Number: 24LR08046
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2024
• 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: 66 YR
• Patient Sex: Female