inforMED
InjuryMSB

CELSIOR

Received Dec 22, 2006 · Event occurred Jul 1, 2004

Report 2950168-2006-00001 · MDR key 799349

Device

Generic name

Organ Preservation Solution

Model number

NI

Catalog number

NA

Lot number

UNK

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

SPONTANEOUS REPORT WAS RECEIVED ON 12/13/2006 AND 12/15/2006 FROM A PHYSICIAN VIA A DISTRIBUTOR AND COMPANY REPRESENTATIVE REGARDING A LIVER TRANSPLANT PATIENT (PATIENT IDENTIFIERS NOT PROVIDED). THE PATIENT RECEIVED A HEPATIC GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR (ELAPSED TIME OF PRESERVATION NOT PROVIDED) IN 2006. THE PATIENT'S MEDICAL HISTORY WAS REMARKABLE FOR ENLARGEMENT OF THE LIVER TRANSPLANT DONOR'S GALLBLADDER PRIOR TO LIVER TRANSPLANTATION AND STATUS POST LIVER TRANSPLANT. IN 2006, AFTER LIVER TRANSPLANT (ELAPSED TIME NOT PROVIDED), THE PATIENT EXPERIENCED DELAYED GRAFT FUNCTION OR ELEVATED TRANSAMINASES WHICH WERE DIFFICULT TO DECREASE. IT WAS THE OPINION OF THE PHYSICIAN THAT THE EVENTS WERE POSSIBLY RELATED TO CELSIOR PRESERVATION EFFICACY. NO FURTHER INFORMATION WAS PROVIDED.