KIWI

Additional Manufacturer Narrative

ATTACHED FILE 'RCA SUBMITTED TO IRB' CONTAINS DETAILED INFORMATION ON DEVICE EVALUATION AND REMEDIATION STEPS PROPOSED.

Description of Event or Problem

THICKNESS BURN ON THE OPPOSING ARM FROM THE DEVICE LEAD. FOLLOWING PI'S PLACEMENT OF THE SINGLE LEAD ON THE CHEST, PI NOTED THE SINGLE LEAD WAS COOL TO THE TOUCH PRIOR TO PLACEMENT AND DURING CALIBRATION. HOWEVER, THE LEAD UNEXPECTEDLY HEATED UP WHILE ON THE SUBJECT. THE LEAD WAS IMMEDIATELY REMOVED, THE BURNS WERE NOTED AND TREATED WITH BACITRACIN AND MEDIHONEY. THE BURNS ON THE RIGHT HAND AND LEFT FOREARM WERE DUE TO THE SUBJECT INADVERTENTLY TOUCHING THE LEAD. PARENTS WERE IMMEDIATELY INFORMED. ON (B)(6) 2024, THE SUBJECT WAS TRANSFERRED TO (B)(6)HOSPITAL FOR WOUND CARE, THE TRANSFER WAS PROMPTED BASED ON THE LOCATION OF THE BURN ON THE RIGHT HAND TO PROVIDE SPECIALIST HAND SURGERY CONSULT THAT WAS NOT AVAILABLE AT (B)(6). AT THAT TIME NO SURGICAL INTERVENTION WAS NEEDED, CONTINUED LOCALIZED TREATMENT WITH SILVER SULFADIAZINE TO CHEST AND RIGHT HAND APPLIED DAILY; XEROFORM AND BACITRACIN TO LEFT FOREARM APPLIED DAILY AND DAILY OCCUPATIONAL THERAPY FOR HAND STRETCHING. THE ADVERSE EVENT WAS REPORTED THROUGH (B)(6) MEDICAL CENTER'S ELECTRONIC SPEAK UP FOR SAFETY HIGH RELIABILITY PORTAL QUALITY VARIANCE REPORT (EQVR) ON THE SAME DAY, (B)(6) 2024, TO BE REVIEWED BY THE HOSPITAL SAFETY TEAM AND RISK MANAGEMENT. THE PI SUSPENDED ENROLLMENT PENDING FURTHER INVESTIGATION. ON 03/12/2024, THE PI GAVE THE DEVICE TO THE SPONSOR'S ENGINEERS TO DETERMINE THE ROOT CAUSE OF THE OVERHEATED LEAD.