BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL CADD ADMINISTRATION SET

    MDR report key: 9336992 · Received November 18, 2019

    Report

    Report Number
    3012307300-2019-06281
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Report Date
    November 19, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALL POSSIBLE SMITHS MEDICAL EXTENSION SETS AND SMITHS MEDICAL ADMINISTRATION SETS REPORTED: CATALOG NUMBERS: 21-7359 & 21-7395, LOT NUMBERS: 3840941 & 3808534.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL CADD ADMINISTRATION SET WAS IN USE, PATIENT RETURNED WITH PUMP SHOWING ZERO RESIDUAL VOLUME; YET OVER 50 CC STILL REMAINED. THE PUMP WAS PROGRAMMED TO DELIVER ETOPOSIDE, DOXORUBIN, VINCRISTINE FOR A TOTAL VOLUME OF 550CC, AT 23CC HOUR FOR 24 HOURS. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130871 SMITHS MEDICAL CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3808534 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1 CADD EXTENSION SET