BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 57531 · Received December 20, 1996

    Report

    Report Number
    1713683-1996-00287
    Event Type
    Malfunction
    Date Received
    December 20, 1996
    Report Date
    December 20, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT CLAMP HOLDER WAS BROKEN. TABS ON WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING INSERTS TO FALL OUT OF HOLDER. IT WAS ALSO DETERMINED THAT RETURNED CLAMP STOP TABS WHICH HOLD CLAMP IN OCCULUDED POSTION WERE EITHER WORN OR BROKEN, SO THAT CLAMP NO LONGER STOPPED SECURELY IN CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF CLAMP FAILS, OPERATOR CAN CLAMP LINE WITH A HEMOSTAT OR INSTALL A LUER CAP ONTO LINE. OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT LINES GOING THROUGH LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWANTED LEAKAGE, EVEN WHEN MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO USER NOT TO USE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNANTICIPATED SALINE LEAKS TO PT CAN RESULT. ABOVE INFO INDICATES THAT LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF CO'S CORRECTIVE ACTION SYSTEM AND MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR #960027.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, A FOUR POSITION LINE CLAMP WAS MISSING TWO OF THE ARMS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    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