D
Patient 1
THE USER REPORTED THAT A DISPOSABLE HAD BROKEN. THE CENTRIFUGE WAS RETURNED, HOWEVER, THE DISPOSABLE WAS NOT. IT WAS OBSERVED THAT THERE WAS AN AMOUNT OF BLOOD SPILLED WITHIN THE CENTRIFUGE CONSISTENT WITH A LEAKING/BROKEN DISPOSABLE. THE CENTRIFUGE WAS CLEANED AND RETESTED AND FOUND TO BE WORKING AS NEW. SINCE THE DISPOSABLE WAS NOT RETURNED THE EXACT MODE OF FAILURE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT, BASED ON DISCUSSIONS WITH THE USER, THE FAILURE OCCURRED AT THE GATE AREA OF THE DISPOSABLE DUE TO A HIGH GATE CONDITION. THOUGH THIS CANNOT BE CONFIRMED. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO ELIMINATE THIS FAILURE MODE. HOWEVER THIS DEVICE WAS SHIPPED PRIOR TO CORRECTIVE ACTION BEING IMPLEMENTED. ALTHOUGH THIS FAILURE INVOLVED LEAKAGE, THE LEAKAGE IS A WASTE PRODUCT OF THE PRP PROCEDURE AND THE LEAKAGE DOES NOT POSE A SAFETY RISK DURING A PROCEDURE IN THAT PRP IS USED AS AN ADJUNCT TO ANY SURGERY AND IS USED AT THE PHYSICIAN'S DISCRETION. THE BLOOD WHICH LEAKED OUT OF THE DISPOSABLE WAS CONTAINED WITHIN THE SEALED CHAMBER OF THE CENTRIFUGE AND WOULD NOT RESULT IN AN INJURY TO THE PT OR USER.