HAEMOTRONIC

Description of Event or Problem

ONE HOUR AFTER PATIENT BEGAN DIALYSIS TREATMENT ON COBE CENTURY 2RX, BLOOD WAS NOTED TO BE LEAKING FROM THE TOP OF THE ARTERIAL CHAMBER. THE TOP OF THE CHAMBER BECAME COMPLETELY DISCONNECTED. APPROXIMATE BLOOD LOSS WAS 250CC. ARTERIAL TUBING WAS CHANGED AND 300 CC NS GIVEN FOR VOLUME LOST.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.