BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREGRAFT 250

    MDR report key: 5013341 · Received August 19, 2015

    Report

    Report Number
    5013341
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 31, 2015
    Manufacturer
    CYTORI THERAPEUTICS, INC.
    Product Code
    MUU
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DRAIN PORT FROM A CYTORI FAT GRAFTING SYSTEM PURE 250 DISCONNECTED FROM THE COLLECTION BAG. THERE WAS NO POTENTIAL IN LOSING GRAFTED FAT, HOWEVER RED BLOOD CELLS, PLASMA, ETC, FROM WASHING AND RINSING OFF THE COLLECTED MATERIAL WAS LEAKING ON FLOOR. NOTES FROM THE OPERATIVE REPORT:.."USING A HAND POWERED 60 ML TOOMEY SYRINGE AND 4 MM MERCEDES TIP CANNULA HARVESTED APPROXIMATELY 500 ML OF FATTY TISSUE ASPIRATE. THIS WAS DIRECTLY INJECTED INTO A CYTORI PUREGRAFT FILTER AND THEN UNDERWENT TWO RINSES OF LACTATED RINGER'S SOLUTION. OF NOTE, THE DRAINAGE PORT FROM THIS FILTER WAS FAULTY AND SEPARATED. FORTUNATELY, WAS STILL ABLE TO FILTER THE ASPIRATE AND USE THE REMAINING PORTS FROM THIS DEVICE." THE PATIENT TOLERATED THE PROCEDURE WELL, AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547877 PUREGRAFT 250 SYSTEM, SUCTION, LIPOPLASTY MUU CYTORI THERAPEUTICS, INC. PUREGRAFT 250/PURE 00040447

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO OTHER THERAPIES