BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PHOTOPHERESIS, PROCEDURAL

    MDR report key: 2250842 · Received August 28, 2011

    Report

    Report Number
    2250842
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 28, 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

    THE PT ARRIVED IN THE OUT PATIENT EXTRACORPOREAL PHOTOPHERESIS (ECP) AREA FOR A REGULARLY SCHEDULED ECP TREATMENT NUMBER 30. TWO PERIPHERAL 18 GAUGE IV'S WERE STARTED AND ECP WAS BEGUN ON THE CELLEX INSTRUMENT (B)(6) USING KIT LOT #Z307/65. WE BEGAN TO HAVE MULTIPLE AIR DETECTED ALARMS AND NOTED MULTIPLE AIR BUBBLES IN THE COLLECT LINE. WE CHECKED THE TUBING CONNECTION TO THE IV HUB TO MAKE SURE IT WAS TIGHT. WE WERE UNABLE TO REMOVE AIR FROM THE LINE OR KIT OR CLEAR ALARMS. BECAUSE OF THIS AND THE FACT THAT AIR WAS BEING PULLED INTO THE KIT THAT IS UNSTERILE, THE TREATMENT WAS ABORTED. BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 250ML AFTER CONFERRING WITH THERAKOS TECH SUPPORT. T-LOCKED PIVS. NOTIFIED DR (BMT), DR (PULMONARY, BIOMED AND ECP LEADERSHIP TEAM.) ASSESSED PATIENT: VS AND PULSE OXIMETER STABLE. PT STATES "I FEEL FINE", STAT COMPLETE BLOOD COUNT SENT. HEMATOCRIT LEVEL DROPPED FROM 34.8 TO 33.6 AND THIS IS WITHIN ECP PARAMETERS. THERE WAS NO APPARENT INJURY TO THE PT OTHER THAN NOTED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PHOTOPHERESIS, PROCEDURAL PHOTOPHERESIS PROCEDURAL KIT LNR THERAKOS INC * Z307/65

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR