FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERFUSION, KIDNEY

MDR report key: 24743642 · Received March 31, 2026

Report

Report Number
MW5186180
Event Type
Malfunction
Date Received
March 31, 2026
Date of Event
November 2, 2025
Report Date
March 26, 2026
Manufacturer
PARAGONIX TECHNOLOGIES, INC.
Product Code
KDN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NM, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ON (B)(6) 2025, AT 0007. (B)(6) REVIEWED AND ACCEPTED A DECEASED DONOR KIDNEY OFFER, AND THE CANDIDATE WAS CALLED IN AND CLEARED TO PROCEED TO THE OPERATING ROOM. AT APPROXIMATELY 0914 A.M., (B)(4) FROM PARAGONIX CONTACTED US TO PROVIDE SUPPORT WITH THE KIDNEY TRANSPORT. DURING THIS CONVERSATION, (B)(4) EXPRESSED CONCERN REGARDING THE PUMP NUMBERS ASSOCIATED WITH THE KIDNEY, INDICATING SHE DID NOT BELIEVE THE VALUES WERE RELIABLE. WHEN STAFF INQUIRED FURTHER, SHE EXPLAINED THAT PARAGONIX HAD ATTEMPTED TO WORK WITH THE OPO THE PREVIOUS NIGHT TO TROUBLESHOOT THE PUMP, BUT THE OPO DECLINED TO PARTICIPATE. MS. (B)(4) THEN BROUGHT (B)(4) (THE INDIVIDUAL INVOLVED IN THE TROUBLESHOOTING ATTEMPTS) INTO THE DISCUSSION. (B)(4) CONFIRMED SHE HAD OFFERED TO ASSIST (B)(6) FROM THE (B)(6), INCLUDING PROVIDING STEP-BY-STEP GUIDANCE VIA VIDEO CALL, BUT HE REFUSED, STATING THERE WAS SOFT PLAQUE AND HE DID NOT WANT TO "MESS WITH IT." BASED ON THIS INFORMATION, BOTH (B)(4) CONCLUDED THAT THE PUMP READINGS WERE UNRELIABLE AND THAT THE KIDNEY LIKELY HAD NOT BEEN PROPERLY PUMPED OVERNIGHT. AT NO TIME DID (B)(6) NOTIFY (B)(6) OF ANY POTENTIAL ISSUES WITH THE KIDNEY OR ITS PERFUSION STATUS. THIS LACK OF COMMUNICATION DIRECTLY IMPACTED OUR DECISION-MAKING PROCESS AND ULTIMATELY LED (B)(6) TO DECLINE THE KIDNEY. VALUES UNRELIABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
808522 SYSTEM, PERFUSION, KIDNEY SYSTEM, PERFUSION, KIDNEY KDN PARAGONIX TECHNOLOGIES, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other