SENSICA POWER CORD REPLACEMENT KIT

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE WIRES OF SENSICA DEVICE¿S POWER CORD WERE EXPOSED. PER THERE WERE 3 POWER CORDS GIVEN BY THE NURSING STAFF FROM THE UNIT WHERE THEY WITNESSED SPARKS COMING FROM THE POWER CORD. THE EXPOSED COPPER WAS FOUND CONSISTENT IN ALL 3 SETS OF CORDS.

Description of Event or Problem

IT WAS REPORTED THAT THE 3 POWER CORDS OF SENSICA DEVICE¿S POWER CORD WERE EXPOSED. NURSING STAFF WITNESSED SPARKS COMING FROM THOSE 3 POWER CORDS WHILE IN OPERATION IN THE INTENSIVE CARE UNIT (ICU). THE EXPOSED COPPER WAS FOUND CONSISTENT IN ALL 3 SETS OF CORDS. CUSTOMER WOULD SEND US THE INCIDENT REPORTS SO THAT WE HAVE DATES ON FILE IN WHICH THESE INCIDENTS OCCURRED. PER FOLLOW UP INFORMATION RECEIVED ON 29JUL2022, SERIAL NUMBERS ARE NOT AVAILABLE FOR ANY OF THE SENSICA DEVICES AS THE POWER CORDS WERE REMOVED AT THE TIME OF FAILURE AND REPLACED WITH FUNCTIONING CORDS. THE CORDS HAVE BEEN SENT TO BD. ALL THREE EVENTS INVOLVED PATIENTS AS THE DEVICE HAD TO BE DISCONNECTED FROM POWER AT THE POINT OF CARE WHILE A NEW POWER CORD WAS OBTAINED. ONLY ONE CORD SPARKED. THERE WERE NO PATIENT INJURIES.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE USER RELATED DUE TO INADEQUATE SECUREMENT OF POWER CORD TO SYSTEM. HOWEVER, THIS CANNOT BE CONFIRMED. A DHR REVIEW IS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. THE DEVICE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: THE POWER CORD ASSEMBLY FOR THE BD SENSICA¿ URINE OUTPUT SYSTEM PLUGS INTO THE BASE OF THE STAND. THE CABLE TIE IS PROVIDED FOR CONVENIENCE IN KEEPING THE POWER CORD ATTACHED TO THE SYSTEM. THE TIE IS CONNECTED TO THE POWER PLUG AT THE PLUG END. ADDITIONAL SLOTS IN THE CABLE TIE ALLOWS THE CABLE TO BE USED TO TIE THE ENTIRE POWER CORD ASSEMBLY TO THE SYSTEM STAND. CORRECTION: D,F,H. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.