BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B BRAUN HEMODIALYSIS UNIT

    MDR report key: 1577730 · Received January 7, 2010

    Report

    Report Number
    MW5014298
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 7, 2010
    Manufacturer
    B BRAUN
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2010, THE BIOMEDICAL MEDICAL TECHNICIAN DISCOVERED A PROBLEM WITH THE B. BRAUN DIALYSIS UNIT. HE HEARD AN UNUSUAL SOUND DURING THE DISINFECTION CYCLE. UPON INVESTIGATION, HE DISCOVERED ONE OF THE TUBES IN CLOSE PROXIMITY TO THE SPINNING FPA PUMP HAD NEARLY WORE THROUGH THE TUBING. THE BIOMEDICAL TECHNICIAN CONTACTED B. BRAUN AND WAS TOLD "WE KNOW ABOUT IT" BY ONE OF THEIR SERVICE. THE BIOMEDICAL TECHNICIAN REPLACED THE TUBE, BUT SHORTENED IT TO PREVENT IT FROM TOUCHING THE FPA PUMP TO CORRECT THE SITUATION. ALL DIALYSIS UNITS WERE CHECKED. ALL 14 UNITS HAD TWO LOOSE MOUNTING SLOTTED SCREW AT THE MOTOR MOUNTING AREA WHICH ALLOWED THE AIR ASSEMBLY TO TURN. PICTURES WERE TAKEN OF THE UNIT AND THE AFFECTED TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B BRAUN HEMODIALYSIS UNIT NONE FKP B BRAUN DIALOG + BD13

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other