BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARIDIAN BCT

    MDR report key: 1202334 · Received October 16, 2008

    Report

    Report Number
    MW5008641
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    COBE SPECTRA
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    COBE SPECTRA RUNNING FC-WBC COLLECTION WITH SET LOT# 07P15238 ABORTED PROCEDURE, DUE TO FAILURE OF EQUIPMENT TO COLLECT INTENDED PRODUCT. THE EQUIPMENT SUCCESSFULLY PRIMED AND PASSED ALARM TESTS WITHOUT INCIDENT AND COLLECTION PROCEEDED FOR APPROX 1.5 HOURS - WITH NO ALARM CONDITIONS. FOLLOWING QUICK START, THE APHERESIS OPERATOR BEGAN HAVING DIFFICULTY MAINTAINING THE INTERFACE. AFTER TROUBLESHOOTING PROCEDURES WERE UNSUCCESSFUL, THE PROCEDURE WAS PAUSED AT WHICH TIME IT WAS DISCOVERED THAT THE COLLECT LINE WAS NOT IN THE CORRECT POSITION WITHIN THE PUMP ROTOR HOUSING. THIS WAS NOT CLEARLY VISIBLE TO THE OPERATOR POSSIBLY DUE TO THE LARGER DIAMETER OF THE NEW ROTOR CAPS. THE COLLECT LINE WAS FOLDED OVER ON ITSELF, INSTEAD OF BEING CORRECTLY LOADED AROUND THE ROTOR, HOWEVER THE INSTRUMENT CONTINUED TO COLLECT WITHOUT ALARMING. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: HPC, APHERESIS COLLECTION FOR TRANSPLANTATION. EVENT ABATED: NO. EVENT REAPPEARED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARIDIAN BCT FC-WBC SET LKN COBE SPECTRA SPECTRA 07P15238

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization