BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11772834 · Received May 4, 2021

    Report

    Report Number
    2016493-2021-503794
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 8, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MAUDE REPORT FROM THE FDA WHICH STATED, "PT HAD NEW ORDER FOR PRECEDEX INFUSION. INFUSION STARTED 2032 AT LOWEST DOSE PER ORDER: 0.2MCG/KG/H RESULTING IN 4.98ML/H DOSE TO PATIENT. MEDICATION SCANNED THROUGH EPIC AND SENT TO PUMP. CONFIRMED DOSE ON PUMP. AT APPROXIMATELY 2225 PUMP ALARMED AIR IN LINE AND UPON CHECKING THE BOTTLE OF PRECEDEX IT WAS COMPLETELY EMPTY WITH AIR IN LINE DOWN TO ALARIS CHANNEL. MODULE PAUSED. MODULE SETTINGS WERE RECHECKED ON PUMP AND STATED DEXMEDETOMIDINE DRUG AMOUNT: 400MCG DILUENT VOLUME 100ML PATIENT WEIGHT (B)(6) TIME UNITS: HOUR DOSING UNITS MCG/KG/H UNITS: 4MCG/ML RATE: 4.98ML/HR VTBI: 80.6ML DOSE: 0.2 MCG/KG/MIN. PUMP MODULE SHUT OFF AND RESIDENT NOTIFIED. CHANNEL AND ASSOCIATED BRAIN TAKEN OUT OF ROOM, TICKET CREATED AND TO BE SENT TO BIOMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669160 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1