BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PROCEDURAL KIT

    MDR report key: 3962818 · Received July 17, 2014

    Report

    Report Number
    3962818
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CELLEX ALARM #43 - PRIME 10 - X3 DURING PRIME -- BIOMED ENGINEER MADE SOME ADJUSTMENTS TO THE INSTRUMENT AND PRIME COMPLETED WITHOUT ADDITIONAL ALARMS. AT 1083ML WHOLE BLOOD PROCESSED (WBP) NOTED INCREASED AIR IN THE AIR FILTER COMPARTMENT INSTEAD OF BLOOD -- LOWERED WBP TARGET TO 1083ML AND PROCEEDED TO BUFFY COAT COLLECTION. BUFFY COAT OBTAINED BUT IT HAD TO BE RETURNED TO THE PATIENT MANUALLY BECAUSE THE RETURN BAG EMPTIED BEFORE THE TREATMENT BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420370 CELLEX PROCEDURAL KIT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NOT APPLICABLE.