CELLEX PHOTOPHERESIS SYSTEM

Additional Manufacturer Narrative

THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION CENTRIFUGE BOWL LEAK/BREAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT: P159 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCE'S ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT: P159 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THE ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4) (B)(6). ON (B)(6) 2026.

Description of Event or Problem

THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL BREAK/LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE AT THE BEGINNING OF THE TREATMENT. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR EVALUATION.