BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 5054005 · Received September 3, 2015

    Report

    Report Number
    2016493-2015-00627
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 17, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF AN OVER INFUSION OF DILTIAZEM WAS NOT CONFIRMED. REVIEW OF THE PCU EVENT LOGS INDICATES THAT THE USER PROGRAMMED AN INFUSION OF "IV FLUID WITHOUT K" TO RUN AT 150ML/HR, WITH A VTBI OF 400ML AT 1:14 PM ON (B)(6) 2015, AND A BASIC SECONDARY INFUSION TO RUN AT 5ML/HR WITH A VTBI OF 75ML. THE USER CLEARED THE VOLUME WHILE THE BASIC SECONDARY INFUSION WAS STILL RUNNING AND HAD 5.33ML LEFT TO INFUSE. THE SECONDARY INFUSION COMPLETED AND THE DEVICE TRANSITIONED TO THE PRIMARY INFUSION RATE OF 150ML/HR. THIS INFUSION RAN FOR APPROXIMATELY 28 MINUTES UNTIL THE DEVICE WAS CHANNELED OFF. THE PRIMARY VOLUME INFUSED UP TO THIS POINT WAS 72.173ML. THE SYSTEM WAS THEN POWERED ON APPROXIMATELY 30 MINUTES LATER AND THE USER PROGRAMMED ANOTHER INFUSION OF "IV FLUID WITHOUT K" TO RUN AT 250ML/HR WITH A VTBI OF 480ML. THE INFUSION COMPLETED APPROXIMATELY TWO HOURS LATER AND THE DEVICE TRANSITIONED TO KVO. THE PUMP MODULE WAS THEN CHANNELED OFF, WHICH SHUT DOWN AND POWERED OFF THE SYSTEM. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 552.38ML FOR THE PRIMARY INFUSION AND 75.004ML FOR THE SECONDARY INFUSION. THE ROOT CAUSE WAS NOT DETERMINED. NO DEVICE WAS RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED PROGRAMMING INFORMATION TO CONFIRM WHAT THEY SUSPECT TO BE A PROGRAMMING ISSUE. THE PATIENT WAS STARTED ON DILTIAZEM ON (B)(6). ON (B)(6) AT 0315 THE NURSE REPORTED THAT WHEN SHE CLEARED THE PUMP IT HAD 30 ML DILTIAZEM (CONCENTRATION 125 MG/125 ML) LEFT TO INFUSE, WITH A RATE OF 5 ML/HR. THE PATIENT WAS IN AFIB/AFLUTTER WITH A HEART RATE IN THE 70'S-80'S AND BLOOD PRESSURE WAS STABLE. TWO HOURS LATER WHEN THE PATIENT WAS NOTED TO BE BRADYCARDIC, WITH HEART RATE DIPPING INTO THE 40'S BRIEFLY THEN RETURNING TO THE 60'S, THE PUMP WAS FOUND TO BE INFUSING AT 150 ML/HR WITH 300 ML LEFT TO INFUSE, BUT THE BAG WAS NEARLY EMPTY. HIS BLOOD PRESSURE WAS 103/70, AND HE WAS ASYMPTOMATIC. THE PHYSICIAN ORDERED A 500 ML NS BOLUS. THE PATIENT'S HEART RATE CAME BACK UP TO THE 60'S-70'S, AND BLOOD PRESSURE CAME UP TO THE 110'S-120'S SYSTOLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586712 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention