BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1311555 · Received November 10, 2008

    Report

    Report Number
    2020550-2008-00026
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 29, 2008
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FPK
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTS THAT ALLEGEDLY AT THE BEGINNING OF A GYNECOLOGICAL PROCEDURE, THE PT BEGAN BLEEDING. THE EQUIMAT UNIT MEASURED +300CC'S, WHICH WAS ATTRIBUTED TO THE BLEEDING. FOUR 3000ML BAGS WERE USED AND THE CASE LASTED 20 MINUTES. BY THE END OF THE CASE, THE EQUIMAT SHOWED A DEFICIT OF -200CC'S. PT HAD A SODIUM LEVEL OF 115 AND WAS SUFFERING FROM HYPERNATREMIA. PT SPENT 24 HRS IN ICU AND WAS RELEASED FROM THE HOSP AFTER A TOTAL OF 48 HRS. PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ EQUIMAT - FLUID MEASUREMENT DEVICE FPK KARL STORZ GMBH & CO. KG 20302020-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other