BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 10556998 · Received September 18, 2020

    Report

    Report Number
    3012307300-2020-09553
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 18, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT: POSSIBLE UNDER INFUSION. PUMP ALARMING EMPTY AND BAG WAS FULL. PATIENT CALLING BECAUSE BAG IS ALMOST FULL BUT PUMP IS STATING EMPTY. LABEL ON BAG STATES DURATION 24 HRS 83 ML/HR VOLUME 2000. PUMP WAS PUT ON 1130-12 ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016846 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1