CELLEX PHOTOPHERESIS SYSTEM

Additional Manufacturer Narrative

THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR DUE TO THE REPORTABLE MALFUNCTION CENTRIFUGE BOWL LEAK/BREAK. SINCE THIS REPORTABLE MALFUNCTION IS ASSOCIATED ONLY WITH THE KIT, THIS MDR WILL BE ONLY AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT P340 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P340 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. AN INVESTIGATION HAS BEEN PERFORMED BASED ONLY ON THE CUSTOMER COMPLAINT DESCRIPTION; NEITHER THE KIT NOR ANY KIT COMPONENTS WERE RETURNED. NO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION EITHER. THE CENTRIFUGE BOWL LEAK/BREAK HAS BEEN VERIFIED BY SERVICE PERFORMED BY THERAKOS, HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME; THIS INVESTIGATION IS NOW COMPLETE. (B)(4). (B)(6). 18/JUN/2026.

Description of Event or Problem

THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT CENTRIFUGE BOWL LEAK/BREAK OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY FIVE MINUTES OF TREATMENT HAD OCCURRED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO PICTURES WERE TAKEN, AND THE KIT WAS DISCARDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.