Description of Event or Problem · 0
BRIEF DESCRIPTION: A (B)(6) PARTICIPANT WAS UNDERGOING THE 2 MONTH POST-SURGERY QUANTITATIVE SENSORY TESTING AT STUDY SITE AT (B)(6) HOSPITAL, (B)(6) ON (B)(6) 2022. DURING THE HEAT THRESHOLD TASK, THE PROBE CONTINUED TO HEAT UP ALTHOUGH THE PARTICIPANT HAD HIT THE TRIGGER THAT SHOULD HAVE STOPPED THE INCREASE IN HEAT. THE RESEARCH COORDINATOR IMMEDIATELY REMOVED THE PROBE. SUBSEQUENTLY THE DEVICE GENERATED SEVERAL ERROR MESSAGES, AND THE COORDINATOR STOPPED THE TASK, AND REPORTED TO THE STUDY PI. LATER THAT EVENING THE PARTICIPANT'S PARENT REPORTED THAT THE CHILD HAD A BURN ON HER ARM, AND SOUGHT CARE AT URGENT CARE WHERE A SECOND DEGREE BURN WAS DIAGNOSED. BACKGROUND AND ADDITIONAL DETAILS: THE INCIDENT OCCURRED AROUND 4PM PST (B)(6) 2022 UTILIZING A THERMAL SENSORY ANALYZER 2001, QSENSE CPM, MEDOC LTD, ADVANCED MEDICAL SYSTEMS, ISRAEL (2018, SERIAL NUMBER (B)(4), FDA 510K CLEARANCE ¿ K922052). WHILE WAITING BETWEEN THE 4TH AND 5TH HEATS OF THE HEAT THRESHOLD TEST, THE PARTICIPANT STATED THE THERMODE WAS STILL GETTING HOT. THE RESEARCH ASSISTANT IMMEDIATELY REMOVED THE PROBE, AND WHILE DOING SO AN ERROR MESSAGE APPEARED. THE UNIT THEN ENTERED A SAFETY MODE AND COMPLETED SELF TESTING. THE THERMODE WAS NOT ON THE PARTICIPANT DURING THE UNIT SELF TEST AND WAS NOT REAPPLIED TO THE ARM. AFTER THE TEST COMPLETED, THE COORDINATOR ATTEMPTED TO RUN THE UNIT SELF TEST AGAIN AND AN ERROR APPEARED ALMOST IMMEDIATELY AND THE UNIT ENTERED SAFETY MODE. AS NOTED ABOVE, THE PARTICIPANT'S MOTHER CONTACTED THE SITE THAT EVENING AND REPORTED THAT THE CHILD HAD A BURN ON HER ARM. DR. (B)(6) CONTACTED THE FAMILY AND ASKED THEM TO PROCEED TO THE EMERGENCY ROOM FOR EVALUATION. DR. (B)(6) ALSO IMMEDIATELY REPORTED THIS TO STUDY PI, DR. (B)(6). THE FAMILY WENT TO LOCAL URGENT CARE WHERE THE PROVIDER DIAGNOSED A SECOND DEGREE BURN, AND PROVIDED TREATMENT INCLUDING APPLICATION OF SILVADINE AND WRAPPING OF THE ARM. DR. (B)(6) CONTINUED TO FOLLOW CLOSELY WITH THE FAMILY. CONTINUED SYMPTOMS INCLUDED REDNESS BLISTERING AND PAIN AT THE SITE. DR. (B)(6) ALSO REACHED OUT TO THE SURGEON INVOLVED, DR. (B)(6), WHO WILL REACH OUT TO THE PATIENT AS WELL. INITIAL ASSESSMENT: ON REVIEW OF THE STUDY PROTOCOL, THE EQUIPMENT MANUALS, AND THE DEVICE MAINTENANCE LOGS, CALIBRATION WAS CURRENT, WITH THE MOST RECENT CALIBRATION IN (B)(6) 2021. THE PROGRAM SETTINGS INCLUDE A LIMIT OF THE MAXIMUM TEMPERATURE TO 50 DEGREES CELSIUS, WHICH IS THE FDA APPROVED LIMIT OF THE DEVICE. ALL STEPS WERE CONDUCTED ACCORDING TO THE PROTOCOL AND MANUAL, INCLUDING MOVING THE DEVICE AFTER EACH SET OF TRIALS, IMMEDIATE REMOVAL OF THE THERMODE WHEN THE PARTICIPANT REPORTED THAT IT WAS HEATING UP, AND DISCONTINUING THE TASK AFTER RECEIVING ERROR MESSAGES. THE STUDY PROTOCOL FOLLOWS QST PROCEDURES WIDELY USED IN CHILDREN AND ADOLESCENTS WITH NO PRIOR SIMILAR ISSUES DESCRIBED IN THE LITERATURE. THEREFORE, THIS APPEARS TO BE A MALFUNCTION OF THE QSENSE DEVICE, AND THIS IS UNDER REVIEW AS NOTED BELOW. FDA SAFETY REPORT ID# (B)(4).