BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSTEM 3

    MDR report key: 56556 · Received December 17, 1996

    Report

    Report Number
    1713683-1996-00270
    Event Type
    Malfunction
    Date Received
    December 17, 1996
    Report Date
    December 17, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT CLAMP HOLDER WAS BOKEN. 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 OCCLUDED POSTION WERE WITHER WORN OR BORKEN, SO THAT CLAMP NO LONGER STOPPED SECURELY IN CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. 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 GAMBRO HEALTHCARE 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. FAR# 960027. CUSTOMER CONTACTED: NO. SALES/SERVIE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, THE CLAMPS ON THE 4 POSITION LINE CLAMP WERE MISSING/LOOSE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other