D
Patient 1
TECHNOLOGIST WAS PERFORMING "DAILY START-UP" PROCEDURES INCLUDING PRIMING ALL REAGENTS THROUGH REAGENT LINES, AND OBSERVING SYRINGES AND SOLENOIDS FOR PROPER FUNCTIONING, WHEN THE "Y CONNECTOR" TO THE ELECTROLYTE DILUENT TUBING POPPED OFF SUDDENLY DURING THE PRIMING SEQUENCE, SPRAYING THE TECHNOLOGISTS EYES WITH APPROX. 0.5CC OF BUFFER, WHICH CONTAINS PHOSPHORIC ACID. THE TECH. IMMEDIATELY WENT TO THE EYEWASH STATION AND CLEANSED EYES 8 MIN, THEN WENT TO THE EMERGENCY DEPARTMENT FOR MORE THOROUGH RINSING WITH 500CC SALINE USING A MORGAN LENS. IT WAS LATER DETECTED, THROUGH CONTACT WITH THE MANUFACTURER, THAT BECKMAN HAD NEGLECTED TO INSTALL A SPLASH GUARD WHEN THE ANALYZER WAS INSTALLED. SPLASH SHIELD INSTALLED 2/21/92 BY BECKMANDEVICE 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-FEB-92. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, OTHER, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.