BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION ALARIS PC

    MDR report key: 8009201 · Received October 25, 2018

    Report

    Report Number
    MW5080846
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 13, 2018
    Report Date
    October 16, 2018
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN INITIATED DILTIAZEM (CARDIZEM) AT 10MG/HR (10ML/HR) 40 MINS AFTER THE 125ML BAG WAS STARTED, THE PT DEVELOPED BRADYCARDIA (^ 50) AND RN NOTED. ALMOST THE ENTIRE BAG HAD INFUSED. RAPID RESPONSE TEAM WAS CALLED AND ARRIVED, PROVIDED IV FLUID AND IV CALCIUM. (OF COURSE, MEDICATION INFUSION WAS STOPPED). PT WAS ASYMPTOMATIC AT FIRST, WAS TRANSFERRED TO ICU. SHORTLY AFTER ARRIVAL, HE DEVELOPED PROFOUND BRADYCARDIA, THEN SINUS ARREST. HE WAS BRIEFLY PULSELESS AND UNRESPONSIVE. HE RESPONDED TO IV EPINEPHRINE, IV CALCIUM AND FLUIDS. FOLLOWING THIS, HE REMAINED STABLE AND WAS TRANSFERRED TO INTERMEDIATE CARE THE FOLLOWING DAY. REVIEW OF PROGRAMMING HISTORY REVEALED THAT PROGRAMMING OF MEDICATION CONCENTRATION, RATE ETC WAS CORRECT. NURSING, PT SAFETY, AND BIOMED ENGINEERS ALL REVIEWED EVENT, FOUND NO USER ERROR, COULD NOT REPLICATE THE ERROR. BD ALARIS PUMP INFUSION SET LOT #(10) 18083068 SENT TO (B)(6); ALSO CAREFUSION ALARIS PUMP (CHANNEL) MODEL 8100, SN (B)(4), REF# 8100ADXEN917, CAREFUSION (B)(4). DATE OF USE: (B)(6) 2018; DIAGNOSIS OR REASON FOR USE: INFUSION OF CARDIZEM DILTIAZEM, ATRIAL FLUTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846522 CAREFUSION ALARIS PC PUMP "BRAINS" FRN CAREFUSION 303, INC. 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening