BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS VENOUS LINE

    MDR report key: 266087 · Received February 7, 2000

    Report

    Report Number
    266087
    Event Type
    Injury
    Date Received
    February 7, 2000
    Date of Event
    January 13, 2000
    Report Date
    January 14, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROX 2 HRS INTO TREATMENT AT 1340, 10 MIN AFTER PT'S LAST BP AND SAFETY CHECK BLOOD WAS FOUND UNDER PT'S CHAIR. THE VENOUS LINE HAD SEPARATED FROM THE ARTERIAL PORT OF PT'S SPLIT ASH CATH (LINES WERE REVERSED 25 MIN INTO TREATMENT DUE TO INSUFFICIENT BLOOD FLOW). 500 CC NS WAS GIVEN, PT'S VITAL SIGNS WERE STABLE AND PT WAS ALERT. STAT CBC DRAWN AT TIME OF EVENT AND 30 MIN POST EVENT. PT CONTINUED TREATMENT AND WENT TO HOSP FOR OBSERVATION AND A TRANSFUSION OF 2U PACKED RBC'S, VITAL SIGNS REMAINED STABLE THROUGHOUT TREATMENT. THE MACHINE DID NOT ALARM AT TIME OF INCIDENT. EST BLOOD LOSS 300CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS VENOUS LINE VENOUS LINE FKJ FRESENIUS USA 037303-5 9NR 107

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R ALTHIN 1000 DIALYSIS MACHINE, ASH SPLIT CATHETER-| INSERTED 12/23/99.