BEUDAMED
    FDA Adverse Event Other Summary report: N

    9616026-2006-00253

    MDR report key: 728438 · Received June 21, 2006

    Report

    Report Number
    9616026-2006-00253
    Event Type
    Other
    Date Received
    June 21, 2006
    Product Code
    FII
    PMA / PMN Number
    k041005
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY NOR MEDICAL INTERVENTION WAS REPORTED. GAMBRO TECHNICAL SUPPORT EVALUATED THE MACHINE AND VERIFIED THAT THE PRESSURES AND SCALES WERE WITHIN SPECIFICATION. PRIMED THE MACHINE. COMPLETED A PRIME TEST AND 15 MINUTE CVVHDF SALINE RUN. VERIFIED FLUID REMOVAL RATE WAS WITHIN 50 ML SPECIFICATION. THE CUSTOMER WAS INFORMED THAT THE PUMPS WILL SPIN QUICKLY TO CATCH UP IF THERE WAS CLAMPED TUBING OR OTHER OBSTACLE TO OBSTRUCT FLOW. THE MACHINE WAS TESTED AND RELEASED FOR USE. 510(K)# IS K041005

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FII

    Patients

    Seq Age Sex Outcome Treatment
    1