BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2872128 · Received December 5, 2012

    Report

    Report Number
    2016493-2012-00512
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BUMETANIDE 12.5MG WAS PROGRAMMED AS A PRIMARY INFUSION AT A RATE OF 4ML/HR AND A VTBI OF 35.3MLS. AFTER ONE HALF HOURS, THE BAG WAS FOUND EMPTY. THE MD ORDERED THAT THE PT BE MONITORED FOR ANY ELECTROLYTE IMBALANCE. LABS AT 2145 (ORDERED STAT DUE TO THE EVENT) SHOWED NO CRITICAL VALUES AND PT HAD AN IMPROVEMENT SINCE THE 1000 DRAW. THERE WAS NO PT HARM. DURING TESTING BIOMED COULD NOT REPLICATE THE EVENT. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFORMATION WAS PROVIDED.

    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 19 YR Required Intervention ALARIS PC UNIT: SN 12375338| ALARIS PUMP MODULE ADMIN SET: MODEL 2420-0500/ LOT