BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19225817 · Received May 1, 2024

    Report

    Report Number
    3012307300-2024-03245
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 1, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE UNKNOWN. E1 - INITIAL REPORTER PHONE 022 420 64 80 (81). ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. EVENT HISTORY LOG REVIEW WAS NOT APPLICABLE. FUNCTIONAL TESTING WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE THE DOWNSTREAM OCCLUSION (DSO) SENSOR. THE DSO SENSOR WAS REPLACED. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN ERROR FOR ¿NO CASSETTE DETECTION¿. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081128 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown