BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CADD SOLIS VIP

    MDR report key: 22003281 · Received May 12, 2025

    Report

    Report Number
    MW5170199
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Report Date
    May 7, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS THEY HAD A BLOOD CLOT REMOVED FROM THEIR IV ACCESS (PICC LINE) LAST WEEK. MD IS AWARE. PATIENT ALSO REPORTS THEY WENT TO THE HOSPITAL EARLIER TODAY BECAUSE THEIR PUMP WAS "GOING OFF" BUT IT RESOLVED SHORTLY AFTER CHECK IN SO PATIENT WAS SENT HOME. NO FURTHER INFORMATION PROVIDED. IF PROVIDED ON THE FORM, THE PRODUCT LOT NUMBER AND EXPIRATION WERE SYSTEMATICALLY RETRIEVED FROM THE DISPENSING SYSTEM. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. PHOTOGRAPHS WERE NOT PROVIDED. NO SERIAL NUMBER PROVIDED. 2 PRODUCT LOT NUMBERS AND EXPIRATION DATES AVAILABLE, UNKNOWN WHICH PUMP PATIENT WAS USING AT TIME OF EVENT. PRODUCT LOT NUMBER: 3002343; 2023389, EXPIRATION DATE: 3/31/2025; 3/24/2025. REF REPORT: MW5170200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241143 PUMP CADD SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3002343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female