CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION
Received Jan 25, 2010 · Event occurred Jan 10, 2010
Report 1220423-2010-00035 · MDR key 2619042
Device
Generic name
Organ Preservation Solution
Manufacturer
Genzyme Polyclonals S.a.s.Model number
NACatalog number
NA
Lot number
CE215-02
Product problems
- Insufficient Device Problem Information
Patient
55 YR
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
THE PT IS NOT DOING WELL [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010, FROM A HEALTH CARE PROFESSIONAL REGARDING A (B)(6) MALE, CARDIAC TRANSPLANT PT, INITIALS (B)(6). THE PT RECEIVED A CARDIAC GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR ON (B)(6) 2010. MEDICAL HISTORY WAS NOT PROVIDED. POST-TRANSPLANT, THE REPORTER INDICATED "THE PT IS NOT DOING WELL". CONCOMITANT MEDICATION WAS NOT PROVIDED. CAUSALITY AND INTENSITY WERE NOT PROVIDED.
Additional Manufacturer Narrative
MANUFACTURER'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.