InjuryMSB

CELSIOR

Received Dec 17, 2004 · Event occurred Nov 1, 2004

Report 2950168-2004-00006 · MDR key 560683

Device

Generic name

Organ Preservation Solution

Manufacturer

Federa Limoges Sas

Model number

Catalog number

Lot number

Product problems

Unknown (for use when the device problem is not known)

Patient

UNKNOWN

Therapy/non-surgical treatment, additional
Hospitalization required

Narrative

Description of Event or Problem

SPONTANEOUS REPORT RECEIVED IN NOVEMBER 2004 FROM AN INSTITUTION REGARDING A HEART TRANSPLANT PT (IDENTIFIERS NOT PROVIDED). THE PT RECEIVED A HEART TRANSPLANT ON AN UNSPECIFIED DATE IN NOVEMBER 2004. CELSIOR SOLUTION WAS USED IN THE HEART TRANSPLATATION. AFTER THE TRANSPLANT THE PT INITIALLY HAD POOR HEART FUNCTION AND WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PT IMPROVED AND WAS TAKEN OFF ECMO. THE PT'S OUTCOME IS UNK. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. NO FURTHER INFORMATION WAS RECEIVED. MANUFACTURER'S COMMENT: THIS IS THE THIRD OF THREE CASES PROVIDED BY THIS REPORTER. PLEASE REFER TO CELS-10010 AND CELS 10011.