Description of Event or Problem · 0
ON (B)(6) 2025, DURING SETUP OF THE OCS HEART SYSTEM, A DIAGNOSTIC ALARM INDICATING "BLOOD WARMER FAILURE" WAS TRIGGERED UPON INSTALLATION OF THE HEART PERFUSION MODULE. A HARD RESET WAS ATTEMPTED WITHOUT RESOLUTION. THE HARD RESET ALLOWED THE SYSTEM TO START UP AND ACHIEVED THE PRIMING TEMPERATURE OF 37°C DESPITE THE ALARM. AFTER PLACING THE HEART ON THE OCS, THE SYSTEM FAILED TO MAINTAIN THE TARGET TEMPERATURE OF 34°C. MULTIPLE ATTEMPTS TO RESEAT THE MODULE AND REMOTE TROUBLESHOOTING WERE UNSUCCESSFUL. THE ORGAN WAS ULTIMATELY NOT TRANSPLANTED DUE TO INABILITY TO MAINTAIN PERFUSION TEMPERATURE. INVESTIGATION SUMMARY: THE PERFUSION MODULE WAS RETURNED TO TRANSMEDICS FOR EVALUATION, AND NO ABNORMALITIES WERE FOUND IN THE BLOOD WARMER ELEMENT. THE OCS CONSOLE WAS ALSO RETURNED. THE REPORTED HEATER ERRORS WERE CAUSED BY THE SYSTEM DETECTING ABNORMAL ELECTRICAL CURRENT IN THE HEATER CIRCUITRY BASED ON THE REVIEW OF THE SESSION FILES. HOWEVER, THE ISSUE COULD NOT BE REPRODUCED DURING TESTING. AS A RESULT, THE INVESTIGATION WAS INCONCLUSIVE, AS THE UNDERLYING CAUSE COULD NOT BE CONFIRMED. A REVIEW OF HISTORICAL COMPLAINTS HAS DETERMINED THIS APPEARS TO BE AN ISOLATED INCIDENT AS THIS SPECIFIC FAILURE MODE HAS NOT BEEN OBSERVED PREVIOUSLY.