CELSIOR

Description of Event or Problem

A PRELIMINARY REPORT HAS BEEN RECEIVED FROM A PHYSICIAN CONCERNING A PATIENT WHO UNDERWENT BILATERAL PULMONARY TRANSPLANTATION IN 2003. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT DRUGS HAVE NOT BEEN SPECIFIED. CELSIOR WAS USED AS SOLID ORGAN PRESERVATION. IN PRE-OPERATIVE PERIOD, THE PATIENT REC'D SEVERAL IMMUNOSUPPRESSIVE AGENTS SUCH AS STEROIDS, CELLCEPT (MYCOPHENOLATE MOFETIL) AND AN UNSPCIFIED ANTI-CALCINEURIN. THYMOGLOBULINE (RABBIT ANTI-THYMOCYTE) WAS INFUSED BEFORE DECLAMPING. SUDDENLY DURING THE SURGICAL PROCEDURE, THE PATIENT DEVELPED MASSIVE HYPERKALAEMIA (UNSPECIFIED BLOOD POTASSIUM LEVEL) EVOLVING TO CARDIAC ARREST. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT DIED. NO AUTOPSY WAS PERFORMED. THE PHYSICIAN CONSIDERED THAT A CAUSAL RELATIONSHIP WITH CELSIOR AND THYMOGLOBULINE CANNOT BEEN EXCLUDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FOLLOW-UP RECEIVED IN OCTOBER 2003 FROM THE SURGEON: THREE LITERS OF CELSIOR WERE USED FOR FLUSHING OF LUNGS AND 1 LITER WAS USED BEFORE THE TRANSPLANTATION OF RETROGRADE PNEUMOPLEGIA OF RIGHT LUNG. THE PATIENT RECEIVED USUAL IV FLUIDS, INCLUDING BLOOD AND SCAVENGED BLOOD. AT TIME 1:36 AFTER THE BEGINNING OF THE SURGICAL PROCEDURE, BLOOD POTASSIUM LEVEL WAS AT 4.3 MEQ/L. CLAMPING WAS PERFORMED AT TIME 3:00 (BLOOD POTASSIUM: 4.9 MEQ/L). TWENTY MINUTES LATER, ANASTOMOSIS OF RIGHT LUNG WAS PERFORMED (BLOOD POTASSIUM 5.3 MEQ/L, 5.4 MEQ/L AT 4:31) AT 5:50, THE FIRST LUNG WAS DECLAMPED. THYMOGLOBULINE WAS STARTED AFTER THE DECLAMPING OF THE FIRST LUNG AND BEFORE DECLAMPING OF THE SECOND LUNG, AT A USUAL DOSE (1-1.5 MG/KG) AND INFUSION RATE (PLANNED OVER 6 HOURS). AFTER DECLAMPING OF THE SECOND LUNG, BLOOD POTASSIUM HAD RAISED TO 7 MEQ/L (TIME 6:21) AND AT 7:00 THE PATIENT PRESENTED WITH ASYSTOLE. DESPITE RESUSCITAION ATTEMPTS INCLUDING BICARBONATE AND LACTATE INFUSIONS, THE PATIENT DIED 8 HOURS AFTER THE BEGINNING OF THE PROCEDURE. THE REPORTER'S CAUSALITY REMAINS UNCHANGED REGARDING CELSIOR AND THYMOGLOBULINE. THE REPORTER CONSIDERED THAT HYPERKALEMIA COULD HAVE HAPPENED PER A POSSIBLE MASSIVE CELLS DESTRUCTION, POSSIBLY DUE TO THYMOGLOBUINE, AND COULD NOT EXCLUDE CELSIOR IN A CONTRIBUTING ROLE. FURTHER INFORMATION HAS BEEN REQUESTED.