CELSIOR
Received Jun 8, 2007 · Event occurred Jan 1, 2007
Report 2950168-2007-00001 · MDR key 863365
Device
Generic name
Organ Preservation Solution
Manufacturer
Cardinal HealthCatalog number
NA
Lot number
CE138-01 OR CE149-01
Product problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Additional Manufacturer Narrative
THIS IS CASE REPORT 1 OF 6 FROM THIS REPORTER.
Description of Event or Problem
HEART GRAFT VENTRICULAR DYSFUNCTION. SPONTANEOUS REPORT REC'D ON 23 MAY 2007 FROM A PHYSICIAN ASSISTANT REGARDING A HEART TRANSPLANT PT (IDENTIFIERS NOT PROVIDED). THE PT REC'D A HEART GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR (DATE OF TRANSPLANT AND ELAPSED TIME OF PRESERVATION WERE NOT PROVIDED) IN 2007. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. DURING OR IMMEDIATELY POST THE HEART TRANSPLANT (ELAPSED TIME NOT PROVIDED), THE PT EXPERIENCED HEART GRAFT VENTRICULAR DYSFUNCTION AND DIED. IT WAS THE OPINION OF THE PHYSICIAN ASSISTANT THAT THE EVENT WAS SEVERE IN INTENSITY AND POSSIBLY RELATED TO CELSIOR. NO FURTHER INFO WAS PROVIDED.