CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION
Received Jan 27, 2012
Report 2950168-2012-00008 · MDR key 2434732
Device
Generic name
Organ Preservation Solution
Manufacturer
Genzyme Polyclonals S.a.s.Model number
UNKCatalog number
UNK
Lot number
CE-262-02
Product problems
- Insufficient Device Problem Information
Patient
UNK
- No Code Available
Narrative
Description of Event or Problem
ACUTE GRAFT FAILURE [GRAFT DYSFUNCTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A HEALTH PROFESSIONAL REGARDING AN ORGAN TRANSPLANT PT, INITIALS NOT REPORTED. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED CELSIOR SOLUTION FOR UNSPECIFIED ORGAN PRESERVATION, DOSE REGIMEN NOT PROVIDED. ON AN UNK DATE, TIME AFTER CELSIOR NOT REPORTED, 2 PTS HAD ACUTE GRAFT FAILURE AFTER THIS LOT OF CELSIOR WAS USED. THIS LOT WAS USED IN A TOTAL OF 3 PTS. THE OUTCOME FOR THE EVENT OF ACUTE GRAFT FAILURE WAS UNKNOWN. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY AND CAUSAL RELATIONSHIP OF THE EVENT TO CELSIOR WERE NOT PROVIDED. THIS IS 1 OF 2 CASES CREATED FOR THIS REPORTED INFO. PLEASE REFER TO CELS-1000024 FOR THE OTHER CASE.
Additional Manufacturer Narrative
NO FURTHER DETAILS WERE RECEIVED. FURTHER INFO HAS BEEN REQUESTED.