CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03,05 report with the FDA on 2009-05-01 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION manufactured by Genzyme Polyclonals S.a.s..

Event Text Entries

[1156156] Partial thrombosis of portal vein (portal vein thrombosis). Case description: report received on 06 march 2009 from an unpublished literature report. This is a literature report entitled, "celsior preservation fluid in liver transplantation: results of a prospective, multicenter study. Grandadam s et al. " the literature describes a one-year, prospective, center, study to assess the results from a total patients who received donor livers for which recovery was performed using celsior solution. Data compared liver allograft outcomes following graft recovery with celsior preservation fluids. The article describes some patients across transplant centers in other country that experienced adverse events with celsior. The male liver transplant patient received a liver transplant in 2002. The patient's medical history was unknown. 11 days after celsior exposure, the patient experienced partial thrombosis on the right and median branches of the portal vein. Donor recovery was performed by the conventional technique. Donor livers were perfused in situ by gravity with celsior solution at 4 degrees c. When only aortic annulation was used, 4l celsior solution was rapidly perfused through the aorta at the beginning of the procedure. Where both aortic and mesenteric vein cannulation were used, 2 l was perfused through each route. A further 1l was perfused slowly during the recovery procedure. The biliary tract was rinsed ex situ with an additional 100ml. During storage, the liver was completely immersed in at least 1l solution and maintained at 4 degrees c until transplantation. Transplantation was performed by the piggyback technique i. E. Preserving the retrohepatic vena cava. Portal, arterial, and biliary anastomoses were performed according to the local expertise of each center. Immediately prior to revascularization, the liver was washed with 500 ml of 4% human albumin solution at 4 degrees c via the portal vein. The rewarming period was defined as the time which elapsed between portal vein declamping and arterial declamping. The patient's outcome, concomitant medications, and the intensity of the event were not provided. It was the opinion of the author that the event was possibly related to celsior.
Patient Sequence No: 1, Text Type: D, B5


[8459331] The accompanying unpublished literature article summarizes the results of a celsior study conducted by a group of investigators independent of genzyme. Upon request, the authors of the literature article provided a tabular listing of celsior adverse events that provided individual patient identifiers. The cases described had previously been reported to genzyme during the course of the study. The authors concluded that this prospective, multicenter study suggests that liver preservation with celsior is efficient and safe. The benefit-risk relationship of celsior is not affected by this report. Journal: unpublished literature. Author: grandadam et al. Title: celsior preservation fluid in liver transplantation: results of a prospective, multicenter study.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2950168-2009-00006
MDR Report Key1374451
Report Source01,02,03,05
Date Received2009-05-01
Date of Report2009-03-06
Date of Event2002-08-22
Date Mfgr Received2009-03-06
Date Added to Maude2009-05-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer ContactWYTSKE KINGMA, MD
Manufacturer Street675 WEST KENDALL STREET
Manufacturer CityCAMBRIDGE MA 02139
Manufacturer CountryUS
Manufacturer Postal02139
Manufacturer Phone8007454447
Manufacturer G1GENZYME POLYCLONALS S.A.S.
Manufacturer Street58 AVENUE DEBOURG
Manufacturer CityLYON
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION
Generic NameORGAN PRESERVATION SOLUTION
Product CodeMSB
Date Received2009-05-01
Model NumberNA
Catalog NumberNA
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGENZYME POLYCLONALS S.A.S.
Manufacturer AddressLYON FR


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2009-05-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.