BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 4397155 · Received December 30, 2014

    Report

    Report Number
    4397155
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 30, 2014
    Manufacturer
    TERUMO BCT, INC
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING TREATMENT AND DURING THE PROCEDURE ONE OF THE PLASTIC TUBES DEVELOPED A SMALL CRACK. THE MD WAS NOTIFIED AND RINSE BACK DONE. DURING RINSEBACK ANOTHER MACHINE WAS PRIMED WITH NEW TUBING. ONCE THE RINSE BACK WAS COMPLETED THE PATIENT WAS DISCONNECTED FROM ONE MACHINE AND IMMEDIATELY CONNECTED TO ANOTHER AND THE TREATMENT RESUMED UNTIL COMPLETION. THIS WAS NOT A MALFUNCTION OF THE MACHINE BUT A CRACK IN THE DISPOSABLE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859627 SPECTRA OPTIA SEPARATOR, AUTOMATED LKN TERUMO BCT, INC * 11W3106

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR