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 00,01,05 report with the FDA on 2012-01-03 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..

Event Text Entries

[16924797] After de-clamping, heart did not restart spontaneously [complications of transplanted heart]. Case description: spontaneous report received from a surgeon on (b)(6) 2011 regarding 4 unspecified heart transplant pts, initials not provided. Celsior administration info was not provided. Pt history was not reported. The surgeon reported that in 5 pts the transplanted heart did not restart spontaneously after de-clamping. In 2 of the pts the heart restarted after drug administration. One restarted after extracorporeal membrane oxygenation (ecmo), one pt died, and the last pt was on ecmo at the time of this report. Concomitant medications were not reported. Intensity was not provided. Causal relationship to thymoglobulin was considered possibly related. This is 1 of 5 reports of heart graft dysfunction from this surgeon. The complete list of cases created from this report include (b)(4). Mfr's comment: no further details were received. Further info has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2950168-2012-00002
MDR Report Key2404323
Report Source00,01,05
Date Received2012-01-03
Date of Report2011-12-21
Date Mfgr Received2011-12-21
Date Added to Maude2012-01-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJILL ROBINSON, R, PH, MBA
Manufacturer Street675 WEST KENDALL ST
Manufacturer CityCAMBRIDGE MA 02142
Manufacturer CountryUS
Manufacturer Postal02142
Manufacturer Phone6177689000
Manufacturer G1GENZYME POLYCLONALS, S.A.S.
Manufacturer Street58 AVE 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 NameNONE
Product CodeMSB
Date Received2012-01-03
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENZYME POLYCLONALS S.A.S.
Manufacturer AddressLYON FR


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-01-03

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