CELSIOR NA

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 2007-06-08 for CELSIOR NA manufactured by Cardinal Health, Zi Nord.

Event Text Entries

[670010] Heart graft ventricular dysfunction. Spontaneous report received on 23 may 2007 from a physician assistant regarding a heart transplant patient (identifiers not provided). The patient received a heart graft that had been preserved with celsior (date of transplant and elapsed time of preservation were not provided) in 2007. The patient's medical history was not provided. During or immediately post the heart transplant (elapsed time not provided), the patient experienced heart graft ventricular dysfunction. It was the opinion of the physician assistant that the event was possibly related to celsior. No further information was provided. Manufacturer's comment: this is case report 6 of 6 from this reporter for additional case reports of heart graft ventricular dysfunction.
Patient Sequence No: 1, Text Type: D, B5


[7973706] .
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2950168-2007-00006
MDR Report Key863312
Report Source05
Date Received2007-06-08
Date of Report2007-05-23
Date of Event2007-01-01
Date Mfgr Received2007-05-23
Date Added to Maude2007-06-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIAN ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactCHRISTINE GRANFIELD
Manufacturer Street500 KENDALL STREET
Manufacturer CityCAMBRIDGE MA 02142
Manufacturer CountryUS
Manufacturer Postal02142
Manufacturer G1CARDINAL HEALTH
Manufacturer StreetRUE DE DION BOUTON BP 1547
Manufacturer CityLIMOGES CEDEX 9 87021
Manufacturer CountryFR
Manufacturer Postal Code87021
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELSIOR
Generic NameORGAN PRESERVATION SOLUTION
Product CodeMSB
Date Received2007-06-08
Catalog NumberNA
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key847546
ManufacturerCARDINAL HEALTH, ZI NORD
Manufacturer AddressRUE DE DION BOUTON BP 1547 LIMOGES CEDEX 9 FR 87021


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2007-06-08

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