CADD-SOLIS WIRELESS COMMUNICATION MODULE

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE DURING IMPLEMENTATION - WIRELESS COMMUNICATION MODULE INTERMITTENT CONNECTION AND THERE WAS A BURNING SMELL WHEN THE BATTERY WAS CONNECTED. THE EVENT OCCURRED UPON OPENING AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS THE FIELD SERVICING ENGINEER. THIS WAS NOT REPORTED TO FDA, AND THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H3, H6: 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.

Additional Manufacturer Narrative

D9: PRODUCT RECEIVED DATE 7/24/2024. H3: ONE DEVICE WAS RETURNED FOR REPAIR IN NEW CONDITION WITH END USER LABELS ATTACHED BUT THE TOP COVER WAS LOOSELY CLOSED. NO SIGN OF PHYSICAL DAMAGE OR IMPACT OBSERVED. THE REPORTED PROBLEM AS REPLICATED. THERE WAS NO INDICATION OF POWER OR CHARGING FUNCTION WHEN THE MODULE WAS ATTACHED TO THE PUMP. THE TOP COVER WAS REMOVED FOR INSPECTION AND FOUND THE INTERNAL BATTERY LEFT HANGING UNCONNECTED AS A CHARGING CAPACITOR SHORTED AND BURNED LEAVING BURN MARK ON THE BATTERY. VISUAL INSPECTION CONFIRMED A BURNED CHARGING BOARD CAPACITOR AND A BURNED MARK ON THE BATTERY PACK. THE COMM MODULE WAS DEFECTIVE. THE CAUSE OF THE PROBLEM WAS A BLOWN BOARD CAPACITOR. THE MODULE WAS REPLACED.