BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10332981 · Received July 28, 2020

    Report

    Report Number
    3012307300-2020-07610
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    June 19, 2020
    Report Date
    October 20, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586029639
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ONE CADD ADMINISTRATION SET FROM PART NUMBER 21-7321-24 AND LOT NUMBER 3823360 WAS RECEIVED IN USED CONDITION INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DAMAGES WERE DETECTED ON THE SAMPLE; HOWEVER, THE ARCH HEIGHT PUMP TUBE LOOKED LOW ALMOST FLAT; ALSO USED SAMPLE WAS RECEIVED WITHOUT THE BLUE CLIP. THE SAMPLE WAS SET FOR ACCURACY TESTING USING A PUMP SOLIS VIP PUMP AND A BALANCE METTLER TOLEDO TO LOOK FOR UNUSUAL FUNCTION DURING ACCURACY TEST. NO DISCREPANCIES WERE DETECTED, AND THE TEST SUCCESSFULLY PASSED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED SINCE THERE WAS NO FAULT FOUND WITH THE RETURNED ADMINISTRATION SET.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PUMP WAS RUNNING, BUT IT REPORTED OCCLUSION EVEN THOUGH THERE WERE NONE. IT WAS UNKNOWN IF THE ERROR CONTINUED AFTER THE ADMINISTRATION SET WAS CHANGED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CADD ADMINISTRATION SET REPORTED FAULTY OCCLUSION AND INFLUENCED LESS FLUID BEING DELIVERED THAN THE PUMP REPORTED WAS DELIVERED. IT WAS ALSO REPORTED THAT THERE WAS NO OCCLUSION IN THE ADMIN SET. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798744 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7321-24 3823360 10610586029639

    Patients

    Seq Age Sex Outcome Treatment
    1