Description of Event or Problem · 1
A BAG OF GLUCERNA (1,000 CC) WAS HUNG AT 1:00 A.M. ON APRIL 16, 1993. THE PUMP WAS SET AT 80 CC'S PER HOUR. THE TUBE WAS FLUSHED APPROXIMATELY 4:15 A.M. AND NO PROBLEMS WERE IDENTIFIED. AT 5:00 A.M. THE PUMP BEGAN BEEPING AND THE BAG WAS FOUND EMPTY. THE VOLUME FED REGISTERED 356 CC ON THE PUMP BUT ACTUALLY MORE THAN 1,000 CC HAD INFUSED SINCE THE 3 - 11 SHIFT HAD CLEARED THE PUMP. THE PUMP WAS IMMEDIATELY TURNED OFF.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, FLOWMETER. CONCLUSION: INVALID DATA, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.