BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10121872 · Received June 5, 2020

    Report

    Report Number
    3012307300-2020-05501
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    April 1, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586043239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION ACCORDING MD01-003. NO OBSTRUCTIONS NOR OTHER WORKMANSHIP DEFECTS WERE DETECTED IN NONE OF THE JOINS OF THE PRODUCT, ONLY A KINK WAS DETECTED ON THE PUMP TUBE IN BOTH SAMPLES CAUSED BY THE FFP SYSTEM SINCE THAT IT WAS RETURNED WITHOUT THE BLUE CLIP. THE SAMPLES WERE SET FOR ACCURACY TESTING USING A PUMP SOLIS VIP [CAL. ID: 1.0273; DUE DATE: NOVEMBER 2020] AND A BALANCE METTLER TOLEDO [CAL. ID: 35.0019; DUE DATE: JANUARY, 2021] TO LOOK FOR UNUSUAL FUNCTION. NO DISCREPANCIES WERE DETECTED, TEST SUCCESSFULLY PASSED (SEE RESULTS ON ATTACHMENTS TAB DISPOSABLE ACCURACY TEST REPORT). NO FAULT WAS FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL, ADMIN SET DIDN'T DELIVER CORRECT AMOUNT OF FLUID. THE PUMP WAS SUPPOSED TO DELIVER 1000ML BUT WHEN THE INFUSION WAS DONE IT STILL WAS ABOUT 500ML LEFT IN THE BAG. BIO AGNES DID AN ACCURACY TEST WITH THE SAME PUMP AND 21.7333-24 AND 21-7033.24 WITH MAJOR VARIATION. THE SPECIFIC ADMIN SET 21-2333-24 DELIVERED 27ML OF 50 ML AND THE 21-7033-24 DID DELIVER 49ML OF 50 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585956 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 7333 3860299 10610586043239

    Patients

    Seq Age Sex Outcome Treatment
    1