CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Received Jan 11, 2012

Report 2950168-2012-00005 · MDR key 2426130

Device

Generic name

Organ Preservation Solution

Manufacturer

Genzyme Plyclonals S.a.s.

Model number

UNK

Catalog number

UNK

Lot number

CE262-02

Product problems

Device Operates Differently Than Expected

Patient

UNK

No Code Available

Narrative

Description of Event or Problem

ACUTE ALLOGRAFT FAILURE [COMPLICATIONS OF TRANSPLANTED HEARTED]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2012 FROM AN OTHER HEALTH PROFESSIONAL REGARDING A PT, INITIALS UNK, WITH HEART TRANSPLANT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED CELSIOR SOLUTION FOR ORGAN PRESERVATION, DOSE REGIMEN NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED ACUTE ALLOGRAFT FAILURE. THE ACTION TAKEN WITH CELSIOR TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF ACUTE ALLOGRAFT FAILURE WAS UNK. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY AND CAUSAL RELATIONSHIP OF THE EVENT TO CELSIOR WERE NOT PROVIDED. THIS IS 1 OF 2 CASES FROM THIS RPTR REGARDING ACUTE ALLOGRAFT FAILURE IN PTS THAT REC'D THIS LOT OF CELSIOR. PLEASE REFER TO (B)(4) FOR THE SECOND CASE.

Additional Manufacturer Narrative

MFR'S COMMENT: NO FURTHER DETAILS WERE REC'D. FURTHER INFO HAS BEEN REQUESTED.