Description of Event or Problem · 1
PT. WITH DIAGNOSIS OF ? CVA NEEDED FEEDING TUBE-PATIENT WAS RESPONSIVE ONLY TO PAINFUL STIMULI, UNABLE TO SWALLOW AND HAD NO GAG REFLEX. TUBE WAS PASSED USING CORRECT PROCEDURE. X-RAY FOLLOWING SHOWED TUBE LOCATED IN RIGHT LUNG WITH AN ASSOCIATED LOCULATED PNEUMOTHORAX. FEEDING TUBE REMOVED AND A SURGEON IMMEDIATELY CAMLLED ON CONSULT. NO SURGICAL TREATMENT NECESSARY. VITAL SIGNS EVERY 15 MINUTES, RESPIRATIONS WATCHED CLOSELY, AND REPEAT X-RAYS. AS A RESULT OF THE EVALUATION, PHYSICIANS REQUIRED TO PASS THE FEEDING TUBE ON DIFFICULT PATIENTS. OTHER TYPES OF FEEDING TUBES ARE BEING EVALUATEDDEVICE 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: A DEVICE FROM SAME LOT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER. CONCLUSION: THERE WAS NO DEVICE FAILURE, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.