BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BM11A BLOOD MONITOR PUMP (REFURBISHED)

    MDR report key: 415988 · Received September 5, 2002

    Report

    Report Number
    1423500-2002-01128
    Event Type
    Malfunction
    Date Received
    September 5, 2002
    Date of Event
    August 4, 2002
    Report Date
    August 7, 2002
    Manufacturer
    MESYS
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY TECHNICIAN REPORTED THE BM 11A DIALYSIS DEVICE REMOVED MORE WEIGHT THAN INTENDED DURING A PATIENT TREATMENT. THE MACHINE WAS PROGRAMMED TO REMOVE APPROXIMATELY 0.335 KGS ULTRAFILTRATE BY THE SECOND HOUR OF TREATMENT. HOWEVER, 1.5 KGS WAS ACTUALLY REMOVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT PER TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BM11A BLOOD MONITOR PUMP (REFURBISHED) BLOOD PUMP FKP MESYS BM11A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 400F BLOOD FILTER AND 5M3048 AND 5M3046 BLOODLINES