BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP PUMP

    MDR report key: 20620497 · Received November 6, 2024

    Report

    Report Number
    3012307300-2024-12746
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    September 1, 2024
    Report Date
    December 2, 2024
    Manufacturer
    6000 NATHAN LN N
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR ANALYSIS. A FUNCTIONAL AND VISUAL TEST WERE PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE CAUSE OF THE REPORTED ISSUE WAS UNKNOWN. AS A RESULT, THE OPTIC SWITCH AND BATTERY DOOR WERE REPLACED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ERROR CODE 41622 WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132132 CADD-SOLIS VIP PUMP PUMP, INFUSION FRN 6000 NATHAN LN N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown