BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOOD MONITOR PUMP

    MDR report key: 86684 · Received January 30, 1995

    Report

    Report Number
    86684
    Event Type
    Other
    Date Received
    January 30, 1995
    Date of Event
    September 19, 1994
    Report Date
    September 26, 1994
    Manufacturer
    BAXTER HEALTHCARE CORP. RENAL DIV. REGULATORY AFFAIRS
    Product Code
    FII
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ERRATIC OPERATION MANIFESTED THROUGH VARIOUS ERROR CODES. UPON SYSTEM RESET, ERROR SELF CORRECT. ON THIS DATE OF EVENT, PUMP STOPPED TWICE WHILE BEING USED ON THIS PT. THE PUMP WAS REMOVED FROM THE PT AND FULL HEMODIALYSIS INITIATED WITH A DIFFERENT PRODUCT. THE VENDOR SERVICE AGENT WAS CONTACTED AT ONCE. TWO COMPUTER BOARDS WERE REPLACED BY VENDOR. THE PUMP STOPPED AGAIN WITHIN 24 HOURS OR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD MONITOR PUMP HEMODIALYSIS UNIT BLOOD PUMP FII BAXTER HEALTHCARE CORP. RENAL DIV. REGULATORY AFFAIRS BM-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other