BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA APHERESIS SYSTEM

    MDR report key: 1217060 · Received October 26, 2008

    Report

    Report Number
    1217060
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 26, 2008
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "SPECTRA APHERESIS SYSTEM WAS REPAIRED BY GAMBRO EQUIPMENT SERVICE TECHNICIAN. REPAIR WAS REPLACEMENT OF CRACKED CENTRIFUGE HOUSING. EQUIPMENT WAS USED PROPERLY THE FOLLOWING DAY. AT START OF PROCEDURE (APPROX 09:25) EQUIPMENT ALARMED, INDICATING BLOOD SPILL IN CENTRIFUGE CHAMBER. TUBING IN CENTRIFUGE CHAMBER WAS BROKEN, CAUSING BLOOD LEAKAGE. PROCEDURE TERMINATED. PATIENT, ON ECMO CIRCUIT, EXPERIENCED A MINIMAL (50 - 100 ML) BLOOD LOSS. NO OTHER PATIENT HARM OCCURRED. UPON EXAMINING EQUIPMENT, TWO TABS WERE NOTED IN THE HORIZONTAL ROUND OPENING OF THE CENTRIFUGE HOUSING. THESE TABS ARE NOT ON THE OTHER, IDENTICAL, APHERESIS MACHINES. IT APPEARS THAT ONE OF THESE TABS HAD CONTACT WITH THE TUBING AND THE FRICTION THAT OCCURRED WITH THE MOVEMENT OF THE TUBING WITHIN THE CENTRIFUGE CAUSED THE TUBING TO BREAK. NO FURTHER TREATMENT OF THE PATIENT RELATED TO THIS INCIDENT WAS REQUIRED. THE PATIENT UNDERWENT THE ORDERED APHERESIS PROCEDURE WITH ANOTHER APHERESIS MACHINE.====================== MANUFACTURER RESPONSE FOR SPECTRA APHERESIS SYSTEM, SPECTRA APHERESIS SYSTEM======================MANUFACTURING ISUUE THE TWO TABS WERE NOTED IN THE HORIZONTAL ROUND OPENING OF THE CENTRIFUGE HOUSING. THESE TABS ARE NOT ON THE OTHER, IDENTICAL, APHERESIS MACHINES. IT APPEARS THAT ONE OF THESE TABS HAD CONTACT WITH THE TUBING AND THE FRICTION THAT OCCURRED WITH THE MOVEMENT OF THE TUBING WITHIN THE CENTRIFUGE CAUSED THE TUBING TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN GAMBRO BCT, INC. SPECTRA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR