LIFEPORT KIDNEY PERFUSION PACK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-18 for LIFEPORT KIDNEY PERFUSION PACK manufactured by Emergo Europe/organ Recovery Systems.

Event Text Entries

[20934848] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009036
MDR Report Key1238850
Date Received2008-11-18
Date of Report2008-11-18
Date Added to Maude2009-01-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIFEPORT KIDNEY PERFUSION PACK
Generic NameRENAL CASSETTE
Product CodeKDN
Date Received2008-11-18
Lot NumberZ08141
ID NumberLKT-200
Device Expiration Date2013-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerEMERGO EUROPE/ORGAN RECOVERY SYSTEMS
Manufacturer AddressMOLENSTRAAT 15 HAGUE 2613BH NL 2613 BH


Patients

Patient NumberTreatmentOutcomeDate
10 2008-11-18

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