MAUDE Adverse Event Report: PARAGONIX TECHNOLOGIES INC KIDNEYVAULT; SYSTEM, PERFUSION, KIDNEY

Lot Number	KS251000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At the time of the patient's renal transplant, upon removing the cannister assembly from the shipping housing, it was discovered that a portion of the preservation solution had leaked from the canister assembly to the shipper assembly.Upon further inspection, a tear in the closed-circuit tubing was identified approximately at the point in which the tubing came into contact with the peristaltic pump / clasping.The patient was informed of the findings; risks/benefits were discussed and they elected to proceed with transplantation.They have since recovered without any identified adverse effects.

• Brand Name: KIDNEYVAULT
• Common Device Name: SYSTEM, PERFUSION, KIDNEY
• Manufacturer (Section D): PARAGONIX TECHNOLOGIES INC
• MDR Report Key: 24619168
• Report Number: MW5185383
• Device Sequence Number: 8697893
• Product Code: KDN
• UDI-Device Identifier: 00850005470335
• UDI-Public: (01)00850005470335(11)251010(17)270108(10)KS251000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 Lot Number: KS251000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: Black Or African American