Description of Event or Problem · 1
PATIENT UNDER GENERAL ANESTHESIA FOR VITRECTOMY PROCEDURE R EYE. THIRTY MINUTES INTO PROCEDURE ANESTHESIOLOGIST NOTED DECREASE IN CO 2 AND EKG CHANGES AND SUBSEQUENT CARDIAC ARREST. RESUSCITATION WAS UNSUCCESSFUL. POST MORTEM EXAMINATION REVEALED PATIENT DIED DUE TO MASSIVE AIR EMBOLISM. PRIOR TO CODE, SURGEON WAS INFUSING AIR INTO PATIENT'S R EYE AT APPROXIMATELY 40 MM HG VIA 4 MM INFUSION CANNULA. CANNULA CONNECTED BY TUBING TO NEVYAS/BRUCKER AIR DELIVERY SYSTEM MANUFACTURED BY DIVERSATRONICS, INC. AIR DELIVERY SYSTEM EVALUATED AND FOUND TO BE WORKING PROPERLY. *INFUSION CANNULA AND TUBING DISCARDED AFTER PROCEDUREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.