BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMP

    MDR report key: 18997588 · Received March 28, 2024

    Report

    Report Number
    3012307300-2024-01906
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 28, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN. E1: PHONE +49 (0) 441 403-2394. ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND A SCRATCHED LCD LENS. FUNCTIONAL TESTING WAS ABLE TO VERIFY THE REPORTED ISSUE. IT WAS DETERMINED THAT THE DSO SENSOR WAS THE ROOT CAUSE AND WAS REPLACED. THE SERVICE HISTORY REVIEW IDENTIFIED 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 THERE WAS NO CASSETTE RECOGNITION. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985479 CADD SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown