BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL CADD EXTENSION SET

    MDR report key: 9356921 · Received November 21, 2019

    Report

    Report Number
    3012307300-2019-06643
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Report Date
    November 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 502CC OVER 24 HOURS FOR 5 DAYS IN A ROW. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149470 SMITHS MEDICAL CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1