BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUMETRIC INFUSION PUMP

    MDR report key: 69560 · Received February 11, 1997

    Report

    Report Number
    2016493-1997-00012
    Event Type
    Injury
    Date Received
    February 11, 1997
    Report Date
    February 7, 1997
    Manufacturer
    IVAC MEDICAL SYSTEMS
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, HOWEVER, THE USER FACILITY VERIFIED THAT THE SET WAS NOT LOADED CORRECTLY INTO THE INSTRUMENTS MECHANISM. THE USER FACILITY IS AWARE OF THE PROPER LOADING PROCEDURE PER THE DIRECTIONS FOR USE (PAGE 9) THAT STATES TO LOAD THE SET AND VERIFY THAT THE TUBING IS FULLY LOADED INTO THE MECHANISM. CLOSE THE ORANGE LATCH, DO NOT USE THE DOOR TO CLOSE THE ORANGE LATCH. FULLY OPEN THE SET REGULATING CLAMP AND VERIFY THAT THERE IS NO FLUID FLOW IN THE SET DRIP CHAMBER. THE MFR REQUESTED PT INFO, HOWEVER, THE INFO WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    A FREEFLOW OCCURRED. THIS RESULTED IN HYPERTENSION IN THE PT AND INCREASE IN BLEEDING AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUMETRIC INFUSION PUMP PUMP FRN IVAC MEDICAL SYSTEMS 591 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other