Description of Event or Problem · 1
UPON X-RAY DENNIS TUBE FOUND TO BE IN LUNG. WHILE REMOVING THE DENNIS TUBE, BALLOON WITH MERCURY BROKE AND SPILLED INTO LUNGS. UPON INVESTIGATION BALLOON FOUND TO HAVE A TEAR APPROXIMATELY .5MM LENGTH. PRIOR TO INCIDENT PATIENT IN CRITICAL CONDITION WITH DO NOT RESUSCITATE ORDERS. SERIAL CHEST X-RAYS DONE WHICH CONFIRMED MERCURY IN LUNGS. PATIENT EXPIRED (3) DAYS AFTER EVENT OCCURRED. IT CANNOT BE DETERMINED WHETHER EVENT CONTRIBUTED TO DEATH BECAUSE PATIENT WAS IN CRITICAL CONDITION PRIOR TO EVENT AND AUTOPSY WAS REFUSEDDEVICE 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 USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER. RESULTS OF EVALUATION: COMPONENT FAILURE, INCORRECT TECHNIQUE/PROCEDURE, BALLOON. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.