BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HPCA PUMP

    MDR report key: 20556867 · Received October 29, 2024

    Report

    Report Number
    3012307300-2024-12256
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 1, 2024
    Report Date
    January 24, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IT WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN. PLEASE REFERENCE FILE MRN 3012307300-2024-11425-00 FOR ALL DETAILS PERTINENT TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RECHARGEABLE BATTERY IS MISSING, AND THE CASSETTE LOCK GIVES AN ALARM THAT THE CASSETTE WAS PARTIALLY UNLATCHED EVEN WHEN THE CASSETTE IS LOCKED. THE PUMP IS NOT CHARGING OR TURNING ON. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319046 CADD-SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown