BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 176622 · Received July 9, 1998

    Report

    Report Number
    1713683-1998-00108
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    April 8, 1998
    Report Date
    July 11, 1998
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED BACK & CHEST PAIN, HYPERTENSION & SHORTNESS OF BREATH DURING TREATMENT & WAS TRANSFERRED TO INTENSIVE CARE UNIT. LAB ANALYSIS SHOWED HEMOLYSIS. PT ADMITTED AS HYPERTENSIVE EMERGENCY WITH BP 250/150. THERE WAS NO SIGNIFICANT DROP IN HDCT. NOT BELIEVED TO BE RELATED TO RECALL BTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R