Description of Event or Problem · 1
PATIENT ON OPD DIALYSIS, HAVING 3 HOURS X 3 PER WEEK. BETWEEN 35 MIN. AND ONE HOUR AND 50 MIN. THE MACHINE REMOVED EXCESS FLUID DESPITE N/S BOLUS AND COUNTERCORECTIVE MEASURES. UF MODULE WAS RESET. TMP WAS OFF AND THEN FINALLY SHUT OFF. TOTAL FLUID REMOVED 3010 CC WITHIN 1 HR. AND 20 MIN. FLUID DESIRED TO BE REMOVED WAS 2000 CC FOR 3 HR, PERIOD. PATIENT TREATMENT TERMINATED AT 8:30 AM. PATIENT'S VITAL SIGNS 124/60 OFF MACHINE. PATIENT HAD RIGHT HAND AND LEG CRAMPS (PATIENT HAS NEVER HAD CRAMPING PREVIOUSLY). TREATED WITH HYPERTONIC N/S 5CC PLUS 300 CC N/S BOLUS. PRE TREATMENT WEIGHT WAS 67.0 KGM. POST TX WAS 58.4 KGM. FLUID RATES DID NOT REFLECT ACTUAL WEIGHT LOSS DURING TREATMENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-92. 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, COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, FAIL-SAFE SYSTEMS, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.