BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS PHOTOPHERESIS SYSTEM

    MDR report key: 3842968 · Received May 27, 2014

    Report

    Report Number
    MW5036376
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CENTRIFUGE OPTIC BOWL SENSOR READING FAILED TO MAINTAIN AT 150 THRESHOLD LEVEL AS REQUIRED BY MANUFACTURER. WHILE PT UNDERGOING EXTRACORPOREAL PHOTOPHERESIS (SINGLE-NEEDLE MODE) TREATMENT, THE CELLEX CIRCUIT WAS RE-PURGED 2X WITHOUT SUCCESS; THERAKOS WAS CONTACTED BY PHONE; BOTH MANUFACTURER TECH SUPPORT AND ECP RN WENT THROUGH FURTHER TROUBLESHOOTING MEASURES WITHOUT SUCCESS. TRANSFUSION MEDICINE MD AT PT'S BEDSIDE AT THIS TIME EXAMINING PT. PROCEEDED TO EARLY BUFFY COAT STAGE AS WHOLE BLOOD PROCESSED REACHED 626MLS (TREATED SHORT VS. 1,000ML WBP GOAL). NO PT COMPLICATION AFTER PHOTOACTIVATION AND REINFUSION OF BUFFY COAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311826 THERAKOS PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS CELLEX C309

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO