BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 20631060 · Received November 7, 2024

    Report

    Report Number
    3012307300-2024-12917
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 7, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FPA
    UDI-DI
    10610586020315
    PMA / PMN Number
    K942046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT #: POSSIBLE LOT NUMBERS: 4448927, 4387687, 4453463, 6026886. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RATE HAD BEEN SET TO ADMINISTER THE MEDICATION OVER 46 HOURS, BUT THE ENTIRE VOLUME HAD BEEN INFUSED WITHIN 43 HOURS. THE PUMP SETTINGS AND THE COMPOUNDED DRUG VOLUME HAD BEEN DOUBLE-CHECKED, AND EVERYTHING HAD BEEN CORRECT ON THEIR END. THE PUMP HAD NOT ALARMED. THE CONTINUOUS INFUSION RATE HAD BEEN 3 ML/HR, WITH A TOTAL RESERVOIR VOLUME OF 138 ML, ALL OF WHICH HAD BEEN GIVEN. THE STATUS OF THE AIR DETECTOR AND UPSTREAM SENSOR HAD NOT BEEN CHANGED. THE INFUSION LENGTH HAD BEEN PROGRAMMED FOR 46 HOURS, BUT THE PUMP HAD DELIVERED IT OVER 43 HOURS. THE LOCK LEVEL HAD NOT BEEN CHANGED. A CSTD FROM SPIROS HAD BEEN USED TO FILL THE CASSETTE, AND THE PUMP HAD BEEN USED TO PRIME THE EXTENSION TUBING. THE SKU NUMBERS FOR THE ITEMS USED DURING THE INFUSION HAD BEEN ADMIN SET: 21-7047-24 LOT UNKNOWN (POSSIBLE LOTS 4448927, 4387687, 4453463, 6026886) AND CASSETTE: 21-7308-24 LOT UNKNOWN (POSSIBLE LOTS 6022069, 4381266, 6005556, 6012367). THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611659 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC NI 10610586020315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CSTD FROM SPIROS