Description of Event or Problem · 1
DIALYSIS WAS INITIATED AT 1315. TWO HRS INTO TREATMENT, PT COMPLAINED OF CHEST PAIN RADIATING INTO LEFT ARM. NTG WAS GIVEN, EKG DONE AND 02 ON. PT WAS TAKEN OFF DIALYSIS AND SYSTEM WAS RECIRCULATED. DR HERE TO ASSESS PT AND DIALYSIS WAS RESUMED AFTER APPROX 10 MIN OF RECIRCULATION USING THE SAME DIALYSIS AND MACHINE. SYMPTOMS CONTINUED AND AT TIMES WORSENED. ANOTHER EKG WAS DONE. NTG AND MS WERE GIVEN AND ABG'S DONE. PT WAS TAKEN OFF DIALYSIS 40 MIN BEFORE SCHEDULED OFF TIME. CHEST PAIN CONTINUED. AT THAT TIME IT WAS DISCOVERED PT HAD GAINED WEIGHT DURING DIALYSIS TREATMENT, PUTTING PT INTO PULMONARY EDEMA AND CAUSING FACE TO BE EDEMATOUS. SHE HAD GAINED 5.5 KG DURING HER TREATMENT LEAVING HER 8.9 KG ABOVE HER DRY WT. MACHINE DID NOT ALARM AND MACHINE PERAMETERS WERE CHECKED HOURLY AS PER PROTOCOL. PT WAS ADMITTED TO TELEMETRY UNIT AND MONITORED. SHE WAS DIALYZED FOR 2 1/2 HRS TO REMOVE EXCESS FLUID. CARDIAC ENZYMES INCREASED, 320 P CK20, 150A (1/13), CK 408, MB 53.3. PT WAS DIAGNOSED WITH MILD MI. THE DIALYSIS MACHINE WAS REMOVED FROM THE UNIT AND DELIVERED TO MAINTENANCE.DEVICE 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-93. SERVICE PROVIDED BY: INVALID DATA. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, COMPONENT FAILURE, VALVE. CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.