CADD SOLIS COMM MODULE SILEX 802.11

Additional Manufacturer Narrative

D9 DATE RETURNED TO MFG 1/27/2025. ONE DEVICE WAS RECEIVED FOR ANALYSIS. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE WAS RECEIVED IN GOOD CONDITION. THE REPORTED EVENT WAS NOT CONFIRMED AND COULD NOT BE DUPLICATED. BASED ON THE EVALUATION RESULTS, NO FAULT WAS FOUND WITH THE WIRELESS CONNECTIVITY FUNCTIONS OF THE COMM MODULE.

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THERE WERE MULTIPLE COMMON DEVICE NAMES AND CORRESPONDING PRO-CODES ASSOCIATED WITH THIS DEVICE. THE ADDITIONAL NAMES AND CODES ARE LISTED BELOW: D2A. COMMON DEVICE NAME: SET, ADMINISTRATION, INTRAVASCULAR. D2B. PROCODE: FPA. D2A. COMMON DEVICE NAME: ACCESSORIES, PUMP, INFUSION. D2B. PROCODE: MRZ. D2A. COMMON DEVICE NAME: PUMP, INFUSION, PCA. D2B. PROCODE: MEA. D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE EXPIRATION DATE IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. H4. DEVICE MFG DATE: THE REPORTED LOT# 12798149 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 21-2131-25; THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PUMP RANDOMLY HAD AN ISSUE WITH WIRELESS CONNECTION AND POWER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.