BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 57593 · Received December 20, 1996

    Report

    Report Number
    1713683-1996-00255
    Event Type
    Malfunction
    Date Received
    December 20, 1996
    Report Date
    December 20, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT THE CLAMP HOLDER WAS BROKEN. THE TABS ON THE WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING THE INSERTS TO FALL OUT OF THE HOLDER,, IT WASL DETEMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD THE CLAMP IN THE OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT THE CLAMP NO LONGER STOPPED SECURELY IN THE CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. SAFETY ANALYSIS: IF THE CLAMP FAILS, THE OPERATOR CAN CLAMP THE LINE WITHIA HEMOSTAT OR INSTALL A LUER CAP ONTO THE LINE. THE CS3 OPERATOR'S MANUAL, VERSION 1995/10, RECOMMENDS IN SECTION 3-43 THAT THE LINES GOING THROUGH THE LINE CLAMP BE DOUBLE CLAMPED TO ELIMINATE ANY UNWATNTED LEAKAGE, EVEN WHEN THE MACHINE CLAMP IS OPERATING PROPERLY. ALSO, IT SHOULD BE OBVIOUS TO THE USER NOT TO USE THE CLAMP IF IT IS BROKEN. HOWEVER, IF A FACILITY CHOOSES TO USE THE CLAMP WHEN BROKEN AND NOT DOUBLE CLAMP, UNATICIPATED SALINE LEAKS TO THE PATIENT CAN RESULT. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND THE MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSIS, 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 BROKE. 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