Description of Event or Problem · 1
THE VENOUS LEVEL DECTECT ALARM SOUNDED (ON THE DELIVERY SYSTEM). THE BLOOD LEVEL WAS VISUALLY FOUND TO BE NORMAL. MULTIPLE ATTEMPT WERE MADE. UNSUCCESSFULLY, TO CLEAR THE ALARM. DURING THIS ALARM CONDITION SAFETY BACK UPS WILL NOT ALLOW THE BLOOD PUMP TO RUN, THEREFORE, THE ENTIRE EXTRACORPREAL SYSTEM CLOTTED DURING ATTEMPTS TO CLEAR THE ALARM. THIS RESULTED IN AN ESTIMATED BLOOD LOSS OF APX. 250MLS FOR THE PATIENT. AFTER THE SYSTEM WAS TORN DOWN EXAMINATION OF THE BLOOD LINES SHOWED THAT THE VENOUS DRIP CHAMBER FILTER HAD BECOME TO SOUND. THIS SAME FAILURE WITH THE SAME ALARM CONDITION HAPPENED ON TWO OTHER PATIENTS, BUT NO BLOOD LOSS RESULTED. PT. WITH LOSS SHOWED NO ADVERSE SYMPTOMS NOR REQUIRED TRANSFUSION.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, NONE OR UNKNOWN. RESULTS OF EVALUATION: MANUFACTURING, TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.