CELLEX PHOTOPHERESIS SYSTEM

Additional Manufacturer Narrative

THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTIONS ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) AND DRIVE TUBE LEAK/BREAK. SINCE THESE REPORTABLE MALFUNCTIONS ARE ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT P153 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT P153 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) AND DRIVE TUBE LEAK/BREAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE CUSTOMER COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CUSTOMER DESCRIPTION AND THE CUSTOMER-SUPPLIED PHOTOGRAPHS. THE SMART CARD AND KIT WERE NOT RETURNED. THE CUSTOMER-SUPPLIED PHOTOGRAPHS SHOWED THAT THE DAMAGE TO THE DRIVE TUBE OCCURRED NEAR THE UPPER BEARING STOP. IT APPEARS THAT THE DRIVE TUBE WAS RUBBING AGAINST THE EDGE OF THE BEARING RETAINER DURING THE PROCEDURE, CAUSING A WEAR MARK AND MOST LIKELY THE LEAK SITE. KNOWN CAUSES FOR THE REPORTED DRIVE TUBE DAMAGE ARE DUE TO EITHER THE BEARING NOT PROPERLY NESTED/LOADED IN ITS RETAINER OR THE BEARING RETAINER NOT ROTATING FREELY. THIS IS SHOWN IN THE "PHOTOGRAPHS TAKEN DURING INVESTIGATION." ALL DRIVE TUBES ARE LEAK TESTED TWICE DURING MANUFACTURING. ONCE AS PART OF THE BOWL ASSEMBLY AND THEN AGAIN AS PART OF THE KIT ASSEMBLY. AS SUCH, IT IS UNLIKELY A CUT WAS PRESENT AT THE TIME OF TESTING. THE KIT PASSED PRIME, INDICATING THAT THE LEAK WAS NOT PRESENT WHEN THE KIT WAS LOADED. A MANUFACTURING PROCESS WALK DID NOT FIND ANY POSSIBLE CAUSE FOR A WEAR MARK ON THE DRIVE TUBE. NO TWISTING OF THE DRIVE TUBE WAS NOTED IN THE CUSTOMER PHOTOS. DURING LOT RELEASE TESTING (LRT) 32 KITS FROM LOT P153 WERE TESTED WITH NO ISSUES REPORTED. A MATERIAL TRACE OF THE DRIVE TUBE ASSEMBLY AND ITS COMPONENTS USED TO BUILD LOT P153 FOUND NO RELATED NON-CONFORMANCES. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NONCONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. THE ROOT CAUSE OF THE DAMAGED DRIVE TUBE COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME; THIS INVESTIGATION IS NOW COMPLETE. (B)(4), (B)(6) 2026.

Description of Event or Problem

THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER STATED THE DRIVE TUBE HAD A CIRCULAR NOTCH NEXT TO THE BEARING LOCATED NEAR THE CENTRIFUGE BOWL AND PROVIDED PHOTOS TO ILLUSTRATE.THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.