FDA Adverse Event Injury Summary report: N

LIFEPORT KIDNEY PERFUSION PACK

MDR report key: 1238850 · Received November 18, 2008

Report

Report Number
MW5009036
Event Type
Injury
Date Received
November 18, 2008
Report Date
November 18, 2008
Manufacturer
EMERGO EUROPE/ORGAN RECOVERY SYSTEMS
Product Code
KDN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

DURING THE ORGAN TRANSPLANTATION PROCESS, ORGANS GO FROM DONOR TO RECIPIENT. THE INTERVENING TIME IS THE 'PRESERVATION' PERIOD. THERE ARE SEVERAL METHODS TO PRESERVE AN ORGAN IN BOTH STATIC AND ACTIVE MODALITIES. ABOUT 25% OF THE KIDNEYS IN THE US ARE PRESERVED VIA PULSATILE PERFUSION OR MACHINE PRESERVATION. MOST OF THOSE CAN BE ATTRIBUTED TO TWO COMPANIES -- WATERS INSTRUMENTS AND ORGAN RECOVERY SYSTEMS -ORS-. RARELY AND FOR OTHER MACHINES, THERE ARE RE-USABLE CASSETTES FOR KIDNEYS BUT USUALLY THEY ARE SINGLE USE/SINGLE PT DEVICES. WATERS AND ORS ARE OF THE SINGLE USE STYLE, WITH WATERS BEING ON THE MARKET FOR SOME 30 YEARS AND ORS FOR ABOUT 4. I HAVE AND CONTINUE TO USE BOTH SYSTEMS. HOWEVER, I HAVE CONCERNS FOR THE ORS CASSETTES. RECENTLY, I'VE SPOKEN WITH OTHER PEOPLE WHO USE ORS AND THEY REPORT ANECDOTALLY A SIMILAR EXPERIENCE AS I HAVE WITH LEAKING CASSETTES. SOMETIMES, THE FLUID LEAKS OUT OF THE CASSETTE WITH SUFFICIENT VOLUME TO POTENTIALLY COMPROMISE THE KIDNEY. SEVERAL TIMES I HAVE CONTACTED THE MFR AND THEY ADVISE SHIPPING THE CASSETTE, SO THEY CAN "HAVE A LOOK AT IT" AND REPLACE IT FOR US. HOWEVER, THE SITUATION SEEMS TO BE ROUTINE AS TIME GOES BY. THEY HAVE REPORTED THAT MY PROBLEM HAS BEEN ADDRESSED WITH THE ASSEMBLERS BUT THEY STILL OCCASIONALLY LEAK. A FEW TIMES IT HAS BEEN IN THE BOTTOM OF THE CASSETTES BUT THE LAST COUPLE OF TIMES, IT LOOKS LIKE THE ADDITIVE PORT IS LEAKING. SEEING AS HOW THESE ORGANS ARE GOING INTO IMMUNOLOGICALLY COMPROMISED, IT SEEMS TO ME TO BE WORTHY OF A LOOK-SEE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RENAL PRESERVATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFEPORT KIDNEY PERFUSION PACK RENAL CASSETTE KDN EMERGO EUROPE/ORGAN RECOVERY SYSTEMS Z08141

Patients

Seq Age Sex Outcome Treatment
1