Description of Event or Problem · 1
THE PATIENT ARRIVED IN THE OR AT 2045 ON 3/4/94 AND SURGERY BEGAN AT 2122. DUE TO THE ENLARGEMENT OF THE RIGHT GROIN HEMATOMA, IT WAS FELT THAT THE PATIENT HAD A BRISK BLEED AND EXPLORATION OF THE RIGHT GROIN WAS PERFORMED WHILE THE LEFT LOWER EXTREMITY GREAT SAPHENOUS VEIN WAS HARVESTED. THE CANNULATION SITE IN THE RIGHT GROIN WAS REPAIRED. UPON ENTERING THE PERICARDIUM, IT WAS NOTED THAT THE RIGHT VENTRICLE WAS SOMEWHAT DILATED AND THE ACUTE MARGIN AND INFERIOR ASPECT OF THE RIGHT VENTRICLE WAS AKINETIC. THE PATIENT WAS BECOMING HYPOTENSIVE AND PLACED ON CARDIOPULMONARY BYPASS.THE BYPASS WAS COMPLETED AND PATIENT'S HEART DEFIBRILLATED WITH A SINGLE DELIVERY OF 30 JOULES AND RESUMED SINUS RHYTHM. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS, GIVEN PROTAMINE SULFATE AND HEMOSTASIS WAS ACHIEVED. THE ANESTHESIA RECORD INDICATES THE PATIENT EXPERIENCED ACUTE ELEVATED ST WHILE COMING OFF BYPASS WHICH RESOLVED SLOWLY OVER THE NEXT 30 MINUTES. THE STERNUM WAS APPROXIMATED USING STAINLESS STEEL WIRES.THE PATIENT SUDDENLY BECAME BRADYCARDIA AND HYPOTENSIVE. T HE STERNUM WAS REOPENED. IT WAS NOTED THE THE RIGHT HEART WAS DILATED AND THE HEART WAS IN AGONAL RHYTHM. OPEN CARDIAC MASSAGE PRODUCED SYSTOLIC BLOOD PRESSURE OF 60-70. IT WAS NOTED AT THE SITE OF ONE OF THE RV PACING WIRES THAT THERE WAS AIR ESCAPING FROM THE RIGHT VENTRICLE. A NEEDLE WAS PLACED IN THE RIGHT VENTRICLE AND A SIGNIFICANT AMOUNT OF AIR WAS WITHDRAWN. THE PULMONARY ARTERY WAS ASPIRATED AND APPROXIMATELY 3-5CC OF AIR WAS RETRIEVED. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. THE RIGHT VENTYRICLE WAS POORLY CONTRACTILE AND COMPLIANT.AFTER ATTEMPTS TO WEAN THE PATIENT OFF CARDIOPULMONARY BYPASS WITH THE ASSISTANCE OF AN INTRA AORTIC BALLOON WERE UNSUCCESSFUL, THE PATIENT WAS PLACED ON RIGHT VENTRICULAR ASSIST AND WEANED FROM THE CARDIOPULMONARY BYPASS. THE STERNUM WAS CLOSED. THE SURGERY ENDED AT 0720 ON 3/5/94.ACORDING TO THE PERFUSION RECORD, THE PATIENT WAS ON CARDIOPULMONARY BYPASS FOR A TOTAL OF 330 MINUTES. THE CELL SALVAGE LOG SHEET INDICATES HE RECEIVED 3600 ML OF SALVAGED WASHED BLOOD.AFTER REMOVING THE DRAPES FROM THE PATIENT, A 1.5CM THIRD DEGREE BURN ON THE MEDICAL ASPECT OF HIS RIGHT THIGH WAS NOTED. THIS WAS PRESUMABLE FROM A BOVIE. THE BURN WAS EXCISED AND REAPPROXIMATED. THE PATIENT HAD A DIFICULT OST-OPERATIVE COURSE WITH MULTI-ORGAN FAILURE. ON 3/6/94, THE RIGHT VENTRICULAR ASSIST DEVICE WAS REMOVED. ON 3/9/94, HE DEVELOPED PROGRESSIVE HYPOTENSION AND ACIDOSIS AND SUBSEQUENTLY DEVELOPED ASYSTOLE. HE WAS PRONOUNCED DEAD AT 11:29 AM.AIR WAS IDENTIFIED IN THE LEFT VENTRICAL. THERE IS NOT EVIDENCE RELATING THE FLUID WARMER, OTHER THAN THAT THE MANUFACTURER IS CAPABLE OF PASSING AIR IF USED IN AN INCORRECT FASHION, (NOT ACCORDING TO THE MFR OPERATIONAL PROCEDURE).DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-94. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.