ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: THE MACHINE WAS RETURNED TO TERUMO BCT FOR REPAIR AND INVESTIGATION. A SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED CONDITION. THE SERVICE TECHNICIAN NOTICED THAT THE LID MAGNET WAS NOT PROPERLY ALIGNED WHICH CAUSED THE LID TO OPEN AND THE LED LIGHT TURNS OFF BEFORE THE LID LATCHES GIVING A FALSE INDICATION OF BEING CLOSED. IT WAS ALSO NOTED THAT THE MACHINE RUNS WITH THE LID NOT FULLY LATCHED, HOWEVER, AS SOON AS THE MACHINE COMPLETELY STOPS, THE LID POPS OPENS AND THE LED LIGHT TURNS ON. THE MAGNET PLATE AND WINDOW/GASKETS ASSEMBLY WERE REPLACED. THE LATCH AND MAGNET ADJUSTMENT WERE PERFORMED PER MANUFACTURER'S SPECIFICATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
D
Patient 1
THE CUSTOMER REPORTED THAT A SMARTPREP CENTRIFUGE LID LATCH WAS NOT LOCKING PROPERLY AND WAS UNABLE TO START A PROCEDURE. THE DEVICE WAS RETURNED FOR REPAIR AND EVALUATION. UPON EVALUATION OF THE DEVICE, THE TERUMO BCT SERVICE TECHNICIAN NOTED THAT THE CENTIFUGE LID POPPED OPEN WHILE THE ROTOR WAS STILL SPINNING. THERE WAS NOT A DONOR OR PATIENT INVOLVED AT THE TIME OF THE INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System