inforMED
DeathMSB

CELSIOR

Received Dec 17, 2004 · Event occurred Nov 9, 2004

Report 2950168-2004-00004 · MDR key 560691

Device

Generic name

Organ Preservation Solution

Model number

NI

Catalog number

NA

Lot number

CE075-01

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Cardiac Arrest
  • Death
  • Hospitalization required

Narrative

Description of Event or Problem

SPONTANEOUS REPORT RECEIVED ON 30 NOVEMBER 2004 FROM AN INSTITUTION REGARDING A HEART TRANSPLANT PT (IDENTIFIERS NOT PROVIDED). THE PT RECEIVED A HEART TRANSPLANT IN 2004. CELSIOR SOLUTION WAS USED IN THE HEART TRANSPLANTATION. THE PT EXPERIENCED PRIMARY NON-FUNCTION WHERE THE HEART NEVER RESTARTED AND THE PT DIED INTRA-OPERATIVELY. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. THIS IS THE FIRST OF THREE CASES PROVIDED BY THIS REPORTER. PLEASE REFER TO CELS-10011 AMD CELS-10012.