BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1853349 · Received September 30, 2010

    Report

    Report Number
    2016493-2010-00467
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . REVIEW OF THE PC UNIT EVENT LOGS SHOWED AT 10:24:18 AM, THE PC UNIT AND PUMP WERE POWERED ON AND THE PRIMARY PROGRAMMING PARAMETERS FOR THE DRUG INSULIN WERE ENTERED USING GUARDRAILS CUSTOM CONCENTRATION: DRUG AMOUNT = 6 UNITS; DILUENT VOLUME = 100ML; RATE= ML/H; VTBI=100 ML. THE INFUSION COMPLETED AT 11:38:06 AM AND ENTERED INTO KVO MODE. THE AMOUNT INFUSED WAS LISTED AS 100.014 ML. THE PC UNIT AND THE PUMP WERE POWERED OFF AROUND TWO MINUTES LATER. THE TOTAL AMOUNT INFUSED WAS LISTED AS 100.65ML. AT 11:50:36 AM, THE PC UNIT AND PUMP WERE POWERED ON AND THE PRIMARY PROGRAMMING PARAMETERS FOR THE DRUG INSULIN WERE ENTERED USING GUARDRAILS STANDARD CONCENTRATION: CONCENTRATION = 100 UNITS/100 ML; RATE = 6ML/H; VTBI = 100 ML. THE INFUSION WAS STARTED AT 11:52:00 AM. AT 11:53:03 AM THE VOLUME OF 100.65 ML INFUSED WAS CLEARED. EIGHT MINUTES LATER THE DEVICES WERE POWERED OFF. THE CUSTOMER'S EXPERIENCE OF OVER INFUSION OF INSULIN WAS CONFIRMED. THE CAUSE WAS MOST LIKELY A USER PROGRAMMING ISSUE. NO MALFUNCTION OF ANY DEVICE IS BELIEVED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POSSIBLE OVER INFUSION OF INSULIN. INSULIN CONCENTRATION WAS 100 UNITS/100 ML AND IT WAS PROGRAMMED FOR 6 UNITS/H VIA SECONDARY INFUSION. BAG FOUND EMPTY AFTER ONE HOUR AT 11:45 AM. BLOOD SUGAR TESTING WAS DONE AND 50% DEXTROSE GIVEN IV WHEN THE OVER INFUSION WAS SUSPECTED. PT RECEIVED 8 UNITS OF INSULIN SUBCUTANEOUSLY AT 10:00 AM WHICH WOULD ALSO HAVE DECREASED THE BLOOD SUGAR LEVEL. INSULIN DRIP WAS RESTARTED AT 20:45 PM AND DISCONTINUED THE FOLLOWING DAY. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ALARIS PUMP MODULE ADMINISTRATION SET: MODEL UNK,| ALARIS PC UNIT: (B)(4)| LOT# UNK