Description of Event or Problem · 1
THERE WAS A GAS LOSS ALARM WITH NO BLOOD IN CATHETER. CONNECTIONS WERE CHECKED AND THE INTRA-AORTIC BALLOON PUMP WAS RESTARTED. TEN MINUTES LATER THERE WAS ANOTHER GAS LOSS ALARM. THE PERFUSIONIST CHANGED PUMPS. TEN MINUTES LATER THERE WAS ANOTHER GAS LOSS ALARM AND THE PATIENT'S VITAL SIGNS WERE DETERIORATING. PUMP ACTION WAS REDUCED TO THE MINIMUM LEVEL. HEPARIN AND OTHER DRUGS WERE INFUSED. THE PATIENT DIED BEFORE THE CATHETER COULD BE REMOVED. THERE WAS A SMALL LEAK IN THE CATHETER, WHICH WAS SENT BACK TO THE MANUFACTURER. THE SECOND PUMP USED WAS IDENTIFIED AND TESTED. IT PASSED ALL PERFORMANCE TESTSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.