BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 3221206 · Received July 5, 2013

    Report

    Report Number
    1722139-2013-02479
    Event Type
    Other
    Date Received
    July 5, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VOLUMETRIC ACCURACY TESTS WERE PERFORMED AND PUMP INFUSED WITHIN +/-5% SPECIFICATION. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A TPN INFUSION OF 1160 ML STARTED IN THE EVENING AND THE MOTHER OF THE PT FOUND THE BAG STILL FULL IN THE NEXT DAY MORNING DUE TO THE PT WAS CRYING OFF AND ON THROUGHOUT THE NIGHT. THE PUMP SHOWED 2.3 ML WAS INFUSED. THERE WASN'T ANY ALARM NOTED ON THE PUMP. THE USUAL INFUSION IS SET TO START AT 10:00 PM OT 8:00 AM. BAG VOLUME: 1160 ML, VOL TBI: 1140, INR RATE: 103.6, UP RAMP: 1:00, DN RAMP: 1:00, TOT TIME: 12:00, KVO: 0. ON 05/07/2013, THE MOTHER TOOK THE PT TO THE EMERGENCY ROOM (ER) AS INSTRUCTED BY THE HOME CARE PROVIDER. THE PROVIDER'S NURSE MGR PROVIDED THE CLINICAL TESTING RESULTS AS FOLLOWS: THE BLOOD TEST WAS PERFORMED AND NORMAL SALINE 200 ML BOLUS ADMINISTERED IV AND TPN INFUSION STARTED. THE BLOOD SUGAR WAS 301 AND THEN THE SERIAL BLOOD SUGAR TEST WAS PERFORMED UNTIL IT NORMALIZED. ELECTROLYTES LEVELS WERE TESTED BUT THE RESULTS ARE NOT AVAILABLE. THE DIAGNOSIS IN THE ER WAS "NO WORSENING OF CLINICAL CONDITION OR DIABETES", BLOOD SUGAR ELEVATION PROBABLY DUE TO STRESS. THE REPORT ALSO STATES THAT THERE IS NO CHANGE IN THE PT MEDICAL CONDITION AFTER THE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307135 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MED DEVICES GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO Hospitalization