BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1242216 · Received November 19, 2008

    Report

    Report Number
    2016493-2008-00182
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 28, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BIOMED REQUESTED EVENT LOG REVIEW DUE TO OVERINFUSION OF CARDIZEM. BAG OF 100MG/100ML WAS HUNG AT 1540 AFTER IV PUSH DOSE WAS DRAWN FROM BAG AND GIVEN. VTBI 90 ML, RATE 10 ML/HR. PATIENT WENT TO CT AND BECAME FLUSHED RED BEFORE PROCEDURE. WHEN RETURNED FROM SCAN 25 MINUTES LATER, BAG FOUND EMPTY AT 1610. AT END OF PROCEDURE PATIENT TURNED BLUE AND SHORT OF BREATH, WAS TRANSFERRED BACK TO ER, BECAME PURPLE, HYPOTENSIVE AND BARELY RESPONSIVE. TREATMENT OF CALCIUM AND ANOTHER BINDING AGENT WAS GIVEN ALONG WITH EXTERNAL PACING UNTIL INTERNAL PACER TOOK OVER. PATIENT WAS LATER IMPROVED, SITTING UP, CONVERSANT AND NO LONGER BEING PACED. FACILITY UNSURE WHICH DEVICE WAS INVOLVED BUT HAS SENT EVENT LOGS FROM SUSPECTED DEVICE. INVESTIGATION IS ONGOING. FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention ASSOCIATED PCU