BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2081313 · Received April 27, 2011

    Report

    Report Number
    2016493-2011-00288
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 21, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP MODULE WAS RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IN THE PEDIATRIC UNIT, AN AMINOCAPROIC ACID INFUSION WAS PROGRAMMED TO INFUSE AT 50 ML/HR AND WAS TO INFUSE FOR 5 HOURS. AT 1.5 HOURS AFTER BEING HUNG, THE IV BAG WAS EMPTY. ACCORDING TO THE VOLUME INFUSED DISPLAYED ON THE PUMP, THE TOTAL INFUSED WAS 74.49 ML. THE CUSTOMER STATED THE PUMP "WAS ASKING FOR A BATTERY REPLACEMENT". THE PATIENT SUFFERED NO ILL EFFECTS, HOWEVER DID HAVE LABORATORY TESTING (PLATELET AGGREGATE) PERFORMED AFTER THE OVER INFUSION AND WAS PLACED ON TELEMETRY MONITORING IN THE PEDIATRIC UNIT. HE HAS SINCE BEEN DISCHARGED HOME ON ORAL AMICAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R MODEL AND LOT NUMBER UNK| ALARIS PUMP MODULE ADMINISTRATION SET:| ALARIS SYSTEM PC UNIT: (B)(4)| ALARIS PUMP MODULE: (B)(4)