CRIT-LINE CLIP (CLIC) - USB

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE ACTUAL CLIC DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. EXTERIOR INSPECTION REVEALED CORROSION ON THE USB CONNECTOR; HOWEVER THERMAL DAMAGE WAS NOT OBSERVED ON THE USB CONNECTOR. THE RETURNED CLIC DEVICE FAILED TO POWER ON WHEN ATTACHED TO A CLM IV. INTERNAL INSPECTION REVEALED CORROSION AND THERMAL DAMAGE TO THE THE RECEIVER BOARD. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE REPORTED EVENT HAS BEEN CONFIRMED.

Description of Event or Problem

A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A CLIC DEVICE WOULD NOT CALIBRATE. A SAMPLE WAS RETURNED FOR EVALUATION AND THERMAL DAMAGE WAS OBSERVED ON THE RECEIVER BOARD. FOLLOW UP WITH THE BMT REVEALED THAT THE CALIBRATION ISSUE OCCURRED DURING SET UP. A PATIENT WAS NOT CONNECTED TO THE DEVICE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT HE HAD NO IDEA THAT A THERMAL EVENT OCCURRED. THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BIOMED HAS RECEIVED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. THE CLIC DEVICE WAS RETURNED FOR PHYSICAL EVALUATION.