Description of Event or Problem · 1
DURING THE COURSE OF ROUTINE HEMODIALYSIS, PATIENT BECAME UNRESPONSIVE AND AIR WAS NOTED IN THE VENOUS LINE. PATIENT WAS TREATED IMMEDIATELY FOR POTENTIAL AIR EMBOLUS AND CARDIAC RESUSCITATION ENSUED, WITH ATTEMPTS BEING UNSUCCESSFUL. FOLLOWUP INVESTIGATION CONFIRMS AIR BUBBLE DECTOR ON KIDNEY MACHINE WAS ARMED BUT DID NOT ALARM, AND THE ARTERIAL BLOOD TUBING, UPON VISUAL INSPECTION, HAD A 1/2" SLIT. HOSPITAL IS STILL AWAITING THE OFFICIAL CORONER REPORT. KIDNEY MACHINE WAS TESTED BY MANUFACTURER AND PERFORMED WITHIN SPECIFIED TOLERANCE. OTHER EQUIPMENT USED: A/V BLOOD TUBING AND HEMODIALYSER, BOTH MANUFACTURED BY TERUMDEVICE 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-OCT-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, ALARM FAILURE. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.