BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 217554 · Received April 1, 1999

    Report

    Report Number
    1713683-1999-00046
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    March 2, 1999
    Report Date
    March 3, 1999
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    Z-201-7
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CLINIC REPORTED INSUFFICIENT WEIGHT REMOVAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. THE GAMBRO TECHNICAL SERVICES REP REPLACED AN INTERMITTENT 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