BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 144349 · Received January 16, 1998

    Report

    Report Number
    1713683-1998-00003
    Event Type
    Injury
    Date Received
    January 16, 1998
    Report Date
    December 16, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    GAMBRO HEALTHCARE NOTIFIED OF PENDING REPETITIVE MOTION INJURY LITIGATION. EQUIPMENT AND/OR DISPOSABLES INVOLVED NOT NAMED; MDR FILED AGAINST CENTRYSYSTEM 3 (CS3) BECAUSE THE CLINIC WHERE THE PLAINTIFF WAS EMPLOYED AT THE TIME ALLEGED INJURY USES CS3 MACHINES.

    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