BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSYSTEM 3

    MDR report key: 42871 · Received October 11, 1996

    Report

    Report Number
    1713683-1996-00090
    Event Type
    Malfunction
    Date Received
    October 11, 1996
    Report Date
    October 11, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE OF THE ULTRAFILTRATION (UF) PUMP THERMAL FUSE. NO FURTHER INFO AVAILABLE FROM THE FACILITY. A REVIEW OF THE DTF AND CPF HISTORIES IS NOT POSSIBLE SINCE THE MACHINE SERIAL NUMBER IS NOT KNOWN. A SECONDARY SEARCH OF THE DTF HISTORY FOR THIS PRODUCT IS NOT POSSIBLE. THE TECHNICIAN AT THE FACILITY FOUND THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE TO BE OPENED (FAILED). THE FAILED THERMAL FUSE WAS NOT RETURNED FOR INVESTIGATION. IT HAS BEEN SEEN PREVIOUSLY THAT A FAILED THERMAL FUSE IS CAUSED BY THE WAX INSIDE THE FUSE MELTING, WHICH CAUSES THE FUSE TO OPEN. THIS IS WHAT THE FUSE IS DESIGNED TO DO. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT THE WAX MELTS AT THE CORRECT TEMPERATURE. IT IS NOT KNOWN AT THIS TIME WHAT CAUSES THE WAX TO MELT. THERE WERE TWO OTHER INCIDENTS REPORTED WITH THIS ONE. CUSTOMER CONTACTED:N. SALES/SERVICE CONTACTED BY INVESTIGATOR:N TRAINING REQUIRED:N.

    Description of Event or Problem · 1

    DURING S DIALYSIS TREATMENT, IT WAS REPORTED THAT THE UF (ULTRAFILTRATION) PUMP THERMAL FUSE FAILED. THERE WAS NO FURTHER INFO AVAILABLE. THIS MDR WAS INADVERTENTLY NOT REPORTED WITHIN THE ALLOTTED TIME PERIOD.

    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