Description of Event or Problem · 1
THE PNEUMATIC TOURNIQUET DEFLATED DURING A BLOCKING PROCEDURE OF THE RIGHT LEG, CAUSING THE PATIENT TO RECEIVE A BOLUS (250 MG IV) OF BRETYLIUM WITH RESULTING NAUSEA AND TRANSITORY DROP IN BLOOD PRESSURE. THE PATIENT WAS GIVEN A 500 CC BOLUS OF IV FLUID TO RAISE THE BLOOD PRESSURE. SHEWAS DISCHARGED APPROXIMATELY ONE HOUR AFTER THE PROCEDURE IN SATISFACTORY CONDITION.THE PNEUMATIC TOURNIQUET WAS CHECKED OUT BY BIO-MED AND RETURNED TO SERVICE WITH A LARGE PLACARD ON IT STATING THAT THE CHAMBER IS TO BE FILLED BY THE GAS CANNISTER, AND THE GAS CANNISTER IS TO THEN BE REMOVED AND NOT LEFT IN THE FILLING CHAMBER (WHICH WAS ALREADY CLEARLY OUTLINED IN THE INSTRUCTIONS PERMANENTLY ATTACHED TO THE EQUIPMENT). THE CANNISTER WHEN LEFT IN HAS THE POTENTIAL TO ALLOW THE GAS TO LEAK OUT OF THE CANNISTER AND SUBSEQUENTLY THE CHAMBER, WHICH WAS THE DETERMINATION MADE BY BIO-MED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.