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	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis (pd) patient reported the cycler prompted with multiple m31 - air detected in cassette warnings during drain 1 of 4 of treatment.Fluid was seen in the cassette door.The film on the back of the cassette door was loose.The patient was to re-setup the cycler with new supplies and drain in drain 0.Upon follow up, the peritoneal dialysis registered nurse (pdrn) confirmed the reported event.The pdrn stated fluid was noted following the reported m31 air detected in cassette warning cycler alarms and during step 9 of treatment as treatment was cancelled.The patient cancelled treatment and found fluid in the pump module area and on the external of the cassette.The film on the back of the cassette was loose but a hole was not noted.The cause of the fluid leak was unknown.The patient confirmed there were no symptoms, adverse events, or injuries requiring any other medical intervention required as a result of the reported event.The pdrn stated the patient was trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient contacted the on-call nurse for assistance and completed treatment using the cycler after re-setting up supplies on the night of the reported event.The patient has since resumed treatment using the cycler without further issue.The pdrn stated the cycler set (cassette) used was discarded and was no longer available to be returned for investigation.
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
A peritoneal dialysis (pd) patient reported the cycler prompted with multiple m31 - air detected in cassette warnings during drain 1 of 4 of treatment.Fluid was seen in the cassette door.The film on the back of the cassette door was loose.The patient was to re-setup the cycler with new supplies and drain in drain 0.Upon follow up, the peritoneal dialysis registered nurse (pdrn) confirmed the reported event.The pdrn stated fluid was noted following the reported m31 air detected in cassette warning cycler alarms and during step 9 of treatment as treatment was cancelled.The patient cancelled treatment and found fluid in the pump module area and on the external of the cassette.The film on the back of the cassette was loose but a hole was not noted.The cause of the fluid leak was unknown.The patient confirmed there were no symptoms, adverse events, or injuries requiring any other medical intervention required as a result of the reported event.The pdrn stated the patient was trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient contacted the on-call nurse for assistance and completed treatment using the cycler after re-setting up supplies on the night of the reported event.The patient has since resumed treatment using the cycler without further issue.The pdrn stated the cycler set (cassette) used was discarded and was no longer available to be returned for investigation.

• 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: 21944783
• Report Number: 0008030665-2025-01000
• Device Sequence Number: 8534880
• Product Code: FKX
• UDI-Device Identifier: 00840861102709
• UDI-Public: 00840861102709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 24JR08076
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2024
• 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: LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 55 KG