BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10212014 · Received June 30, 2020

    Report

    Report Number
    3012307300-2020-06386
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Report Date
    August 18, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ORACLE RO 1071628: VOLUMETRIC ACCURACY TEST FAILING. ADDITIONAL INFORMATION RECEIVED ON 6-JUN-2020: NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED. DEVICE ANALYSIS COMPLETED AND IN H 10

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING, A SMITHS MEDICAL CADD SOLIS VIP PUMP FAILED VOLUMETRIC ACCURACY TESTING. NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675869 CADD SOLIS VIP FRN ST PAUL 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1