Description of Event or Problem · 1
ON 1/11/92, AT 11:00 AM, THE DEAERATION ALARM SOUNDED FOLLOWING A LOW PRESSURE SHUT DOWN OF THE REVERSE OSMOSIS FEED SYSTEM. THE TECHNICIAN WENT TO CHECK THE C-3 AND UPON HIS ARRIVAL THE PATIENT BEGAN CONVULSING. THE TECHNICIAN URGENTLY CHECKED THE BLOOD LINES AND OBSERVED AIR IN THE VENOUS LINE WHICH HE INSTANTLY CLAMPED OFF. FOR UNKNOWN REASONS, THE AIR BUBBLE DECTOR FAILED TO TRIGGER AND HENCE CLAMPING WAS NOT INITIATED RESULTING IN AIR INFUSION TO THE PATIENT. THE DIALYSIS MACHINE INVOLVED IN PATIENT INJURY WAS IMMEDIATELY IMPOUNDED AND SECURED FOR SIMULTANEOUS MANUFACTURER AND IN-HOUSE BIOMEDICAL PERSONNEL EVALUATION.THE PATIENT SUFFERED A GRAND MEL SEIZURE AND WAS TREATED IN A HYPERBARIC CHAMBER. HE WAS ADMITTED FOR EVALUATION AND RELEASEDTWO DAYS LATER FOLLOWING X-RAY AND ECHOCARDIOGRAPHIC EVALUATIONS. CONCURRENT WITH THIS EVENT, A PATIENT ON ANOTHER DIALYSIS MACHINE WAS FOUND TO HAVE HIGHLY FOAMED BLOOD LINES BUT PATIENT ENTRY WAS PREVENTED BY THE AIR BUBBLE DETECTOR'S CLAMPING JUST BEFORE THE FOAM ENTERED THE FISTULAINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.