MAUDE Adverse Event Report: PARAGONIX TECHNOLOGIES INC PARAGONIX KIDNEYVAULT PORTABLE RENAL PERFUSION SYSTEM

Lot Number	KS250300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record (dhr) for the complaint device (lot #ks250300, serial #: (b)(6)) confirmed that all in-process and final quality control checks were completed with no recorded deviations.The complaint device was returned and investigation performed.Preliminary findings based on the device investigation and image analysis of photographs taken during inspection at the receiving hospital suggest the failure was improper seating of the tubing by the user on the peristaltic pump.This caused the tubing to be abraded into the top pump edge close to the outflow end of the tubing.This abrading likely caused a rough surface.Once there was enough damage to the tube, it appears that the tubing tore resulting in the reported leak.No similar complaints have been reported from the same lot to date.Based on current evidence, this appears to be an isolated event.
Event or Problem Description
At approximately 05:58 on (b)(6) 2025 upon initial inspection at the recipient transplant center, it was noticed that the front of the device was wet and appeared to be actively leaking.

• Brand Name: PARAGONIX KIDNEYVAULT PORTABLE RENAL PERFUSION SYSTEM
• Common Device Name: KIDNEYVAULT
• Manufacturer (Section D): PARAGONIX TECHNOLOGIES INC; 950 winter street; waltham MA 02451
• Manufacturer (Section G): PARAGONIX TECHNOLOGIES INC; 950 winter street; waltham MA 02451
• Manufacturer Contact: randy koester ; 950 winter st; waltham, MA 02451 ; 7742910259
• MDR Report Key: 22804829
• Report Number: 3011175555-2025-00002
• Device Sequence Number: 7836904
• Product Code: KDN
• UDI-Device Identifier: 00850005470335
• UDI-Public: (01)00850005470335(11)250312(17)260610(10)KS250300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K234060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: Health Professional
• Device Expiration Date: 06/10/2026
• Device Lot Number: KS250300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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
• Patient Sex: Unknown