Description of Event or Problem · 1
PATIENT ADMITTED TO HOSPITAL ON 1/14/92 FOR ANGIOGRAM. POSITIVE EXAM FOR BILATERAL SEVERE ILIAC STENOSIS WITH EXTENSIVE PERIPHERAL VASCULAR DISEASE SHOWING OCCLUSION OF THE RIGHT ANTERIOR AND POSTERIOR TIBIAL BRANCHES. TO SURGERY ON 1/15/92 FOR AORTOBIFEMORAL GRAFT. SURGERY WAS UNEVENTFUL. AS NURSES WERE DRESSING THE INCISIONS, THE NURSE ANESTHETIST NOTICED A SUDDEN DROP IN BLOOD PRESSURE AND PULSE, FOLLOWED BY DROP IN OXYGEN SATURATION READINGS WITH CARDIAC RHYTHM ON EKG. NOTED AIR IN TUBING FROM IV INSERTION SITE UPWARDS INTO THE SECONDARY IV TUBING LEADING TO THE BLOOD INFUSION BAG. CLAMPED SITE AND CALLED FOR ANESTHESIA TO RETURN TO THE ROOM. CODE CALLED AS PATIENT WENT INTO FULL ARREST. FULL CODE AND RESUSCITATIVE MEASURES ENSUED WITH CARDIAC CONSULT IN OR. STAT ECHOCARDIOGRAM CONFIRMED LARGED AMOUNT OF AIR IN RIGHT VENTRICULAR OUTFLOW TRACT AND THE MAIN PULMONARY ARTERY. DEVELOPED SEVERE ACIDOSIS AND WAS TRANSPORTED TO ICU WHERE SHE RECEIVED HYPERVENTILATION TO DECREASE PCO2. REPEATEDLY HAD SEVERE EPISODE OF HYPERTENSION TREATED WITH DOPAMINE AND EPINEPHRINE DRIPS. INTERMITTENT BOLUSES OF EPINEPHRINE WERE INITIALLY EFECTIVE IN RAISING BP FROM 60'S TO REASONABLE RANGE. REMAINED UNRESPONSIVE AND KEPT IN TRENDELENBURG POSITION FROM TIME AIR EMBOLISM DISCOVERED IN THE OR. INTERVIEWS WITH THE OR NURSING AND ANESTHESIA STAFF CONFIRMED THAT THE ANESTHESIOLOGIST APPLIED A PRESSURE PUMP TO THE BLOOD INFUSION BAG THAT LED FROM CELL SAVER IN AN EFFORT TO SPEED UP INFUSION OF THE REMAINING BLOOD. THIS IS DIRECTLY AGAIONST THE MANUFACTURER'S GUIDELINES AND A WARNING IS IMPRINTED ON THE INFUSION BAG.THE CELL SAVER WAS REMOVED FROM SERVICE AND UNDERWENT A 4-HOUR EVALUATION BY THE BIOMEDICAL ENGINEER WHO IS MANUFACTURER TRAINED TO SERVICE THE UNIT. THERE WAS NO MALFUNCTION FOUND AND THE UNIT WAS RETURNED TO SERVICE. THE CONCLUSION DRAWN IS THAT THE PATIENT DIED SECONDARY TO INJURY CAUSED BY AIR EMBOLUS THAT WAS CAUSED BY THE WRONGFUL APPLICATION OF A PRESSURE DEVICE TO THE INFUSION BAGDEVICE 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-NOV-91. 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: COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: CAUSED BY ANOTHER DRUG/DEVICE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.