CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-27 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..

Event Text Entries

[2418482] Acute graft failure [graft dysfunction]. Case description: spontaneous report was received on (b)(6) 2012 from a health professional regarding an organ transplant pt, initials not reported. The pt's medical history was not provided. On an unspecified date, the pt initiated celsior solution for unspecified organ preservation, dose regimen not provided. On an unk date, time after celsior not reported, 2 pts had acute graft failure after this lot of celsior was used. This lot was used in a total of 3 pts. The outcome for the event of acute graft failure was unknown. Concomitant medications were not provided. The intensity and causal relationship of the event to celsior were not provided. This is 1 of 2 cases created for this reported info. Please refer to cels-1000024 for the other case.
Patient Sequence No: 1, Text Type: D, B5


[9594579] No further details were received. Further info has been requested.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2950168-2012-00008
MDR Report Key2434732
Report Source05
Date Received2012-01-27
Date of Report2012-01-23
Date Mfgr Received2012-01-23
Date Added to Maude2012-02-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJILL ROBINSON R. PH, MBA
Manufacturer Street675 WEST KENDALL STREET
Manufacturer CityCAMBRIDGE MA 02142
Manufacturer CountryUS
Manufacturer Postal02142
Manufacturer Phone6177689000
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 Received2012-01-27
Model NumberUNK
Catalog NumberUNK
Lot NumberCE-262-02
ID NumberUNK
Device Expiration Date2012-10-18
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. Other 2012-01-27

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