BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 218331 · Received April 10, 1999

    Report

    Report Number
    1713683-1999-00058
    Event Type
    Malfunction
    Date Received
    April 10, 1999
    Report Date
    March 11, 1999
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    Z-201-&
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INSUFFICIENT PATIENT WEIGHT REMOVAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE "GAMBRO" TECHNICAL SERVICES REP REPLACED THE ULTRAFILTRATION PUMP THERMAL FUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT FII GAMBRO HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other