BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 134658 · Received November 26, 1997

    Report

    Report Number
    1713683-1997-00369
    Event Type
    Injury
    Date Received
    November 26, 1997
    Report Date
    November 4, 1997
    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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION AS NOTED IN BLOCK B.5. A SAFETY ALERT REGARDING THE WASTE HANDLING OPTION AND POTENTIAL INFECTIONS HAS BEEN ISSUED, AND OTHER RELATED ACTIVITIES COMPLETED IN CONJUNCTION WITH THE FDA AND THE CENTERS FOR DISEASE CONTROL. A DEFINITIVE LINK BETWEEN THE WASTE HANDLING OPTION AND BLOOD STREAM INFECTIONS HAS NOT BEEN PROVEN, AND IT SHOULD BE NOTED THAT THERE ARE MANY SOURCES FOR BLOOD STREAM INFECTIONS IN DIALYSIS PATIENTS. IN ADDITION, THE FACT THAT THE SAME BACTERIA IS ISOLATED FROM THE MACHINE AS FROM THE PATIENT, AS INDICATED IN THE ATTACHED, IS NOT DEFINITIVE IN DETERMINING THE CAUSE OF THE INFECTION. THE MANUFACTURER IS CONTINUING TO INVESTGATE THESE ISSUES.

    Description of Event or Problem · 1

    ADDED 01-20-99. ADDITIONAL INFORMATION RECEIVED THROUGH LITERATURE BY GAMBRO HEALTHCARE QUALITY ASSURANCE ON 01-20-99 ("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).

    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 NA Required Intervention