BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, CELLEX, PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 2117304 · Received May 29, 2011

    Report

    Report Number
    2117304
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 29, 2011
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED FOR EXTRACORPOREAL PHOTOPHERESIS PROCEDURE (ECP) TREATMENT. SHORTLY AFTER THE TREATMENT WAS BEGUN USING THE CELLEX INSTRUMENT (B) (6), THERE WAS A "CENTRIFUGE BOWL LEAK" ALARM. WE HAD TO ABORT THE KIT AND DETERMINE THE BREACH IN THE KIT STERILITY. THE KIT WAS SEQUESTERED FOR BIOMED. APPROXIMATE BLOOD LOSS = 147ML. THE PT REMAINED ASYMPTOMATIC AND VITAL SIGNS WERE STABLE. A NEW KIT WAS PRIMED ON A DIFFERENT CELL EX INSTRUMENT (B) (6). WE WERE ABLE TO PROCEED WITH ECP AND COMPLETE TREATMENT. NOTE: WE ALSO HAD THREE "BUFFER VOLUME EXCEEDED" ALARMS DURING THIS TREATMENT, POSSIBLY INDICATING A LOWER HEMATOCRIT OR CLOUDY PLASMA. THE PLASMA APPEARED CLEAR. A STAT COMPLETE BLOOD COUNT WAS SENT AT THE END OF THE COMPLETED ECP TREATMENT.

    Description of Event or Problem · 1

    PT ARRIVED FOR EXTRACORPOREAL PHOTOPHERESIS PROCEDURE (ECP) TREATMENT. SHORTLY AFTER THE TREATMENT WAS BEGUN USING THE CELLEX INSTRUMENT #40158, THERE WAS A "CENTRIFUGE BOWL LEAK" ALARM. WE HAD TO ABORT THE KIT AND DETERMINE THE BREACH IN THE KIT STERILITY. THE KIT WAS SEQUESTERED FOR BIOMED. APPROXIMATE BLOOD LOSS = 147ML. THE PT REMAINED ASYMPTOMATIC AND VITAL SIGNS WERE STABLE. A NEW KIT WAS PRIMED ON A DIFFERENT CELL EX INSTRUMENT #40156. WE WERE ABLE TO PROCEED WITH ECP AND COMPLETE TREATMENT. NOTE: WE ALSO HAD THREE "BUFFER VOLUME EXCEEDED" ALARMS DURING THIS TREATMENT, POSSIBLY INDICATING A LOWER HEMATOCRIT OR CLOUDY PLASMA. THE PLASMA APPEARED CLEAR. A STAT COMPLETE BLOOD COUNT WAS SENT AT THE END OF THE COMPLETED ECP TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, CELLEX, PHOTOPHERESIS PROCEDURAL KIT PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT LNR THERAKOS, INC. * Y307/137

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR