InjuryMSB

CELSIOR

Received Dec 17, 2004 · Event occurred Nov 29, 2004

Report 2950168-2004-00005 · MDR key 560830

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 THE PREVIOUS DAY. CELSIOR SOLUTION WAS USED IN THE HEART TRANSPLANTATION. AFTER THE TRANSPLANT THE PT HAD POOR HEART FUNCTION AND WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION. THE PT'S OUTCOME IS UNK. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. NO FURTHER INFO WAS RECEIVED. THIS IS THE SECOND OF THREE CASES PROVIDED BY THIS REPORTER. PLEASE REFER TO CELS-10010 AND CELS-10012.