BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 21006478 · Received December 23, 2024

    Report

    Report Number
    3012307300-2024-15397
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 23, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS 6022118, 6022120, 6005752. H3: THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: POSSIBLE LOT NUMBERS 6022118, 6022120, 6005752 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHOWED NO DISPOSABLE, PUMP WILL NOT RUN. THE PUMP WAS ALARMING, AND THE SCREEN READ STOPPED. SETTINGS REVIEWED: RESERVOIR VOLUME WAS 37.3 ML, RATES WAS 52.0 ML/24 HOURS, GIVEN WAS 62.75 ML. THE PATIENT DENIED ANY AIR IN THE TUBING. HOWEVER, THE CASSETTE WAS REMOVED, AND BUBBLES WERE OBSERVED IN THE TUBING THAT EXTENDS ACROSS THE TOP OF THE CASSETTE. PER REPORTER, THE TUBING WAS MASSAGED AND CASSETTE TAPPED ON A FIRM SURFACE, REATTACHED AND PUMP STARTED. THE SCREEN CONTINUED TO SHOW NO DISPOSABLE, PUMP WILL NOT RUN. THE PATIENT WAS REDIRECTED TO THE CLINIC. THE EVENT OCCURRED AT THE PATIENT'S HOME. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85256 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown