BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION ALARIS IV PUMP

    MDR report key: 8893103 · Received August 13, 2019

    Report

    Report Number
    MW5089004
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 27, 2019
    Report Date
    August 12, 2019
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT 0953, POTASSIUM CHLORIDE 60 MEQ/ 500ML WAS ADMINISTERED AS ORDERED FOLLOWING THE GUARDRAILS SET AS DEFAULT BY THE ALARIS PUMP. INFUSION RATE AT THE PUMP WAS 83.3 ML/HR. HOURLY ROUNDS MADE. AT 1145, WRITER NOTED THAT THE IVPB WHICH WAS SUPPOSED TO BE INFUSED FOR 6 HOURS ENDED UP INFUSING FOR 2 HOURS. THE IVPB WAS ALMOST COMPLETED AND APPROX 50ML WAS REMAINING IN THE BAG. CALLED 2 NURSES TO WITNESS THE FAST INFUSION RATE OF THE SAID IV. MD WAS MADE AWARE AND ASKED HIM IF HE NEEDS THE PT TO BE ON TELE MONITOR AND SAID NOT FOR NOW BUT, TO CONTINUE TO MONITOR THE PT. PHARMACIST WAS ALSO NOTIFIED. PT IS ALERT, ORIENTED X3 AND VERBALLY RESPONSIVE. NO COMPLAINTS OF ANY PAIN AND NO DISTRESS NOTED. VS STABLE. REPLACED THE MACHINE WITH A NEW PUMP. ATTEMPTED TO CALL CAREFUSION (ALARIS) CUSTOMER SERVICE BUT THE OFFICE WAS CLOSED. PUMP LABELED TO BE FIXED. SUPERVISOR ON DUTY WAS NOTIFIED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683841 CAREFUSION ALARIS IV PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8100
    683842 CAREFUSION ALARIS IV PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1