BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO PRISMA FLEX

    MDR report key: 2001707 · Received February 22, 2011

    Report

    Report Number
    2001707
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GAMBRO
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CVVH RETURN LINE BECAME DISCONNECTED WITHOUT MACHINE ALARM. NURSE WAS IN THE ROOM AND IMMEDIATELY CLAMPED THE LINE. PT EXPERIENCED APPROX 200 CC OF BLOOD LOSS. PHYSICIANS NOTIFIED OF EVENT. PT REMAINS UNDER CLOSE OBSERVATION IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO PRISMA FLEX CRRT PUMP KDI GAMBRO

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention