BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 524417 · Received February 12, 2004

    Report

    Report Number
    1423500-2004-00128
    Event Type
    Malfunction
    Date Received
    February 12, 2004
    Date of Event
    January 21, 2004
    Report Date
    January 21, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY NURSE REPORTED THAT 2.5-HOURS INTO A 3-HOUR INTENDED DIALYSIS TREATEMENT ON A SYSTEM 1000 HEMODIALYSIS MACHINE, THE VENOUS NEEDLE BECAME DISLODGED FROM A PT'S FOREARM. THERE WAS NO MACHINE ALARM NOTED. THE PT ALERTED THE NURSE TO THE SITUATION. THE NURSE CLAMPED THE BLOODLINE AND STOPPED THE BLOOD PUMP. APPROXIMATELY 100 ML OF BLOOD WAS LOST FROM THE PT. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. TREATMENT PARAMETERS CONSISTED OF A 300 ML/MIN BLOOD FLOW RATE, 600 ML/MIN DIALYSATE FLOW RATE, AND POST-PUMP ARTERIAL PRESSURE MONITORING. THE PT'S ACCESS IS A FOREARM GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE CORP. SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FRESENIUS F8 DIALYZER, 2004.| MEDISYSTEMS BLOODLINES K39633-9750, 2004,