CELLEX PHOTOPHERESIS SYSTEM

Additional Manufacturer Narrative

THE COMPLAINT KIT AND SMART CARD WERE RETURNED FOR INVESTIGATION. A REVIEW OF THE DATA ON THE SMART CARD SHOWED THAT THE TREATMENT WAS COMPLETED WITHOUT THE OCCURRENCE OF ANY ALARMS, SYSTEM ERRORS, OR WARNINGS. THE KIT WAS RETURNED IN DOUBLE NEEDLE MODE AND THE TREATMENT BAG HAD BEEN CUT AWAY FROM THE REST OF THE KIT. A SYRINGE WAS ATTACHED TO THE NEEDLE FREE INJECTION PORT ON THE TREATMENT BAG AND LIQUID WAS ABLE TO BE PUMPED INTO THE TREATMENT BAG WITHOUT ISSUE. THE REPORT OF AN INJECTION PORT ISSUE WAS NOT CONFIRMED AS WATER WAS SUCCESSFULLY INJECTED INTO THE BAG. THE TREATMENT BAG WAS PRESSURE TESTED TO CHECK FOR LEAKS AND A LEAK WAS VERIFIED COMING FROM THE NEEDLE FREE PORT ON THE TREATMENT BAG. THE CUSTOMER REPORTED THEN USED A NEEDLE TO INJECT METHOXSALEN. THE LEAK COMING FROM THE NEEDLE FREE INJECTION PORT WAS MOST LIKELY DUE TO THE DAMAGE CAUSED BY THE CUSTOMER USING A NEEDLE TO INJECT METHOXSALEN INTO THE NEEDLE FREE INJECTION PORT. A MATERIAL TRACE OF THE NEEDLE FREE PORTS USED TO BUILD LOT L245 DID NOT FIND ANY NON-CONFORMANCES. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. THE ROOT CAUSE OF THE BAG LEAK WAS MOST LIKELY DUE TO THE CUSTOMER USING A NEEDLE TO INJECT METHOXSALEN INTO THE NEEDLE FREE INJECTION PORT. NO MANUFACTURING RELATED DEFECTS WERE IDENTIFIED DURING THE INVESTIGATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4) H.M. 20 JUN 2023.

Additional Manufacturer Narrative

THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW FOR KIT LOT L245 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT L245 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, BAG LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE KIT AND SMART CARD IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4). (B)(6).

Description of Event or Problem

THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A BAG LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THEY FOUND THAT THE TREATMENT BAG WAS LEAKING WHEN ATTEMPTING TO INJECT THE METHOXSALEN. THE TREATMENT WAS COMPLETED, AND BLOOD WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED THE KIT AND SMART CARD FOR INVESTIGATION.