Description of Event or Problem · 1
THE PATIENT WAS A 61 YEAR OLD FEMALE ADMITTED WITH METABOLIC ENCEPHALOPATHY WITH DEHYDRATION. HISTORY OF COPD, ALCOHOLISM, PERIPHERAL NEUROPATHY. WORK-UP DEMONSTRATED GASTRIC ULCER WITH EVIDENCE OF EROSIVE GASTRODUODENITIS. ADMITTED TO ICU WITH PLACEMENT OF SWAN GANZ CATHETER WITH INTRODUCER KIT ON NOVEMBER 7TH, 1992. WAS RECEIVING IV FLUIDS VIA SIDE PORT OF SWAN GANZ CATHETER. DURING EARLY MORNING HOURS OF NOV. 11, 1992 PATIENT APPARENTLY GOT OUT OF BED UNASSISTED, AT SOME POINT DISCONNECTED IV TUBING AND FELL. PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS VIA SIDE PORT OF SWAN GANZ. PATIENT WENT INTO CARDIAC ARREST AND SUBSEQUENTLY DIED. FINAL DIAGNOSIS HYPOVOLLEMIC SHOCK-SECONDAY MASSIVE BLOOD LOSSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, USER EDUCATION PROVIDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.