BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS COMM MODULE

    MDR report key: 21102987 · Received January 8, 2025

    Report

    Report Number
    3012307300-2025-00410
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 1, 2024
    Report Date
    March 5, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    MRZ
    UDI-DI
    15019517171969
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 1/27/2025. ONE DEVICE WAS RETURNED FOR ANALYSIS. REVIEW OF THE EVENT HISTORY LOG (EHL) SHOWED A MULTIPLE OCCURRENCES OF COMMUNICATION MODULE INTERMITTENT CONNECTION. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED, AND THE REPORTED ISSUE WAS NOT DUPLICATED. THE COMPLAINT IS CURRENTLY BEING INVESTIGATED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    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# 13409696 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 CADD SOLIS PUMP WITH THE 2131 COMMUNICATION MODULE GAVE AN ERROR FOR "WIRELESS MODULE INTERMITTENT CONNECTION TO PUMP". THE ALARM SEEMED VERY RANDOM BUT ONLY CAME ON WHEN CONNECTED TO AC POWER SUPPLY. THIS MADE SENSE IF THE BATTERY PACK WAS SOMEHOW GETTING DISCONNECTED. WHEN NOT CONNECTED TO AC POWER SUPPLY, THE UNIT SIMPLY SHUT DOWN WITH NO ALARM. ALL CONNECTIONS WERE CLEAN, AND THE PLASTIC CONTACT COVERS WERE REMOVED BETWEEN THE COMMUNICATION AND THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320847 CADD SOLIS COMM MODULE ACCESSORIES, PUMP, INFUSION MRZ SMITH¿S MEDICAL ASD, INC. 13409696 15019517171969

    Patients

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