BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13472043 · Received February 7, 2022

    Report

    Report Number
    3012307300-2022-02784
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    November 18, 2021
    Report Date
    March 9, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHERE CUSTOMER EXPLAINED THAT THE BACKUP PUMP WAS NOW GIVING A "NO DISPOSABLE CLAMP TUBING" ALARM. PATIENT CONTACTED THE PHARMACY AND WAS ISSUED A NEW PUMP. THEY CONFIRMED CASSETTE WITH LOT 4163625 WAS MALFUNCTIONING. THE PATIENT TRIED THREE PUMPS AND THEY ALL CAME BACK WITH THE SAME ERROR WHEN THE CASSETTE WAS ATTACHED. PATIENT MADE ANOTHER NEW MIX WITH THE SAME CASSETTE FROM THE SAME LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED PER EMAIL MEDWATCH REPORT #MW5105682, REPORT DATE:(B)(6) 2021 REPORTING CASSETTE MALFUNCTION. STATED THAT PATIENT HAS BEEN OFF HER INFUSION FOR ABOUT AN HOUR, TRYING TO TROUBLE SHOOT HER PUMP; "NO DISPOSABLE - PUMP WON'T RUN" ERROR MESSAGE WAS DISPLAYED ON THE SCREEN. TRIED USING A NEW MIX, NEW CASSETTE, NEW TUBING AND SWITCHING THE CASSETTE FROM ONE PUMP TO THE OTHER BUT KEPT GETTING THE SAME ERROR MESSAGE. WAS FINALLY ABLE TO GET THE INFUSION GOING AGAIN. NO PATIENT INJURY WAS REPORTED. (2/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS- DOCUMENTING INCIDENT#2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497165 CADD CASSETTE FPA ST PAUL 7302 4163625 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female