D
Patient 1
THE USER REPORTED THAT THE DISPOSABLE HAD A "CRACK AT THE BOTTOM, NOTICED LEAK AND STOPPED CENTRIGUATION." THE DISPOSABLE WAS RETURNED TO HARVEST AND EVALUATED. IT WAS OBSERVED THAT THE DISPOSABLE HAD APPROX 1CC OF BLOOD REMAINING IN IT. THERE WAS A CRACK AT THE BOTTOM OF THE BLOOD TUBE, ON BOTH SIDES OF THE GATE, EXTENDING APPROX 1 CM AWAY FROM THE GATE ON BOTH SIDES. THE GATE COULD BE SEEN PROJECTING ABOVE THE PROFILE OF THE BLOOD TUBE, THOUGH IT HAD BEEN OBVIOUSLY DEFORMED DURING CENTRIFUGATION DUE TO THE PRESSURE EXERTED ON THE GATE BY THE TRUNION. IT IS LIKELY THIS FAILURE WAS DUE TO THE HIGH GATE CONDITION. ALTHOUGH THE FAILURE CAUSES 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. HARVEST'S SUPPLIER HAS BEEN NOTIFIED AND A FULL CORRECTIVE ACTION PLAN HAS BEEN IMPLEMENTED. THE BLOOD THAT WAS SPILLED WAS CONTAINED WITHIN THE SEALED CHAMBER AND WOULD NOT RESULT IN AN INJURY TO THE PATIENT OR USER. THIS EVENT DID NOT RESULT IN AN EXPOSURE AS DEFINED BY OSHA.