BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CENTRY 3

    MDR report key: 148381 · Received January 9, 1998

    Report

    Report Number
    148381
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    July 19, 1997
    Report Date
    July 29, 1997
    Manufacturer
    COBE RENAL CARE INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT 10" INTO TX WHEN C3 WENT INTO SYSTEM SHUTDOWN. CLAMPS CLOSED. UNABLE TO RINSE VENOUS BLOOD BACK TO PT. UNABLE TO PULL UP ALARM SCREEN TO VERIFY REASON FOR SYSTEM SHUTDOWN. MFR SERVICED POST EVENT 07/18/97 WORKORDER NUMBER W70718EK06. EQUIPMENT UNDER CONTRACT MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRY 3 DIALYSIS MACHINE FII COBE RENAL CARE INC. 333103001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R