BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 210704 · Received February 20, 1999

    Report

    Report Number
    1713683-1999-00036
    Event Type
    Injury
    Date Received
    February 20, 1999
    Report Date
    January 20, 1999
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NOT YET ASSIGNED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO REC'D THROUGH LITERATURE BY GAMBRO HEALTHCARE ("OUTBREAK OF BLOOD STREAM INFECTIONS IN A HEMODIALYSIS UNIT RELATED TO USE OF A DIALYSIS MACHINE WASTE PORT," ASN ABSTRACT, 31ST ANNUAL MEETING, OCTOBER 25-28, 1998, ATTACHED). THE MFR FILED 5 MDR'S WHEN THE INFECTIONS WERE FIRST LEARNED OF IN NOVEMBER, 1997 (REFERENCE 1713683-1997--00367 THROUGH 1713683-1997-00371), BUT THROUGH THIS LITERATURE LEARNED THAT 8 PTS WERE INVOLVED. ADDITIONAL MDR'S ARE NOW BEING FILED TO COVER THE REMAINING 3 PTS.

    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 Hospitalization| R