BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS COMM MODULE SILEX 802.11

    MDR report key: 21102986 · Received January 8, 2025

    Report

    Report Number
    3012307300-2025-00411
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 1, 2024
    Report Date
    March 6, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    PYR
    UDI-DI
    15019517171969
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320846 CADD SOLIS COMM MODULE SILEX 802.11 NEURAXIAL ADMINISTRATION SET - INTRATHECAL DELIVERY PYR SMITH¿S MEDICAL ASD, INC. 12798149 15019517171969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CADD SOLIS HPCA PUMP KIT 2110