BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 20231090 · Received September 16, 2024

    Report

    Report Number
    3012307300-2024-09298
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 16, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME "INFUSYSTEM INC - NORTHWELL CANCER INSTITUE AT RIVERHEAD" NEITHER SAMPLE NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED POSSIBLE LOT NUMBERS 4072206 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 USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A DOWNSTREAM OCCLUSION ALARM WHILE PRIMING. PER REPORTER THEY HAD NOT USED THE 250ML CASSETTE FOR SOME TIME. THEY HAD TROUBLE GETTING THE CASSETTE TO PRIME, THEY TRIED SEVERAL TIMES AND RE-INSTALLING BEFORE IT PRIMED. CLAMPS WERE OPEN AND THEY EVEN TRIED SWAPPING EXTENSION SETS BUT WERE UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464411 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC 4072206 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CADD CASSETTE RESERVOIR 21-7308-24| CADD PUMP