CADD COMMUNICATION MODULE

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. EVALUATION DETERMINED THAT THERE WAS NO INTERNAL BATTERY INSTALLED INSIDE THE COMM MODULE. WITHOUT AN INTERNAL BATTERY THE COMM MODULE COULD NOT OPERATE. REPLACEMENT REQUEST WAS PROCESSED TO THE CUSTOMER.

Additional Manufacturer Narrative

E1: PHONE NUMBER EXTENSION (B)(6). INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE COMMUNICATION MODULE WAS ATTACHED TO THE PUMP, AN ALARM WAS GENERATED STATING THAT THE BATTERIES WERE DEPLETED, YET THEY ARE FULLY CHARGED. THE ALARM ONLY WENT AWAY WHEN THE PUMP IS CONNECTED TO THE POWER ADAPTER. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.