FDA Adverse Event Malfunction Summary report: N

KIDNEYVAULT

MDR report key: 24897402 · Received April 16, 2026

Report

Report Number: 3011175555-2026-00001
Event Type: Malfunction
Date Received: April 16, 2026
Date of Event: April 8, 2026
Report Date: April 15, 2026
Manufacturer: PARAGONIX TECHNOLOGIES
Product Code: KDN
PMA / PMN Number: K234060
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE (LOT #: KC250758, SERIAL #: (B)(6) CONFIRMED THAT ALL REQUIRED INPROCESS AND FINAL QUALITY CONTROL INSPECTIONS WERE COMPLETED, AND NO DEVIATIONS WERE NOTED. THE REPORTED DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS IT WAS DISCARDED BY THE USER FACILITY FOLLOWING THE EVENT. BASED ON THE INFORMATION PROVIDED, THE EVENT IS LIKELY ASSOCIATED WITH IMPROPER TUBING CONFIGURATION WITHIN THE LOWER PORTION OF THE CANISTER, WHICH MAY RESULT IN A SLIGHT KINK AND SUBSEQUENT DISCONNECTION OF THE EXTERNAL TUBING AT THE PULL PORT UNDER PRESSURE WHEN THE PUMP IS ACTIVATED. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

Description of Event or Problem · 0

ON (B)(6) 2026, AT MAUI MEMORIAL MEDICAL CENTER, A LEFT KIDNEY WAS PLACED INTO THE KIDNEYVAULT AND THE PUMP WAS ACTIVATED. UPON ACTIVATION, THE EXTERNAL TUBING CONNECTED TO THE CANISTER BECAME DISCONNECTED AT THE PULL-PORT, RESULTING IN LEAKAGE OF PERFUSION SOLUTION. THE MALFUNCTION OCCURRED IMMEDIATELY AFTER PUMP ACTIVATION AND PRIOR TO TRANSPLANT. THE ORGAN WAS SUBSEQUENTLY DISCARDED DUE TO STERILITY CONCERNS. NO PATIENT INJURY OCCURRED AS THE EVENT TOOK PLACE PRIOR TO TRANSPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
953521	KIDNEYVAULT	KIDNEYVAULT	KDN	PARAGONIX TECHNOLOGIES		KC250758

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other