BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREGRAFT 850 SYSTEM

    MDR report key: 8575792 · Received May 2, 2019

    Report

    Report Number
    3011277972-2019-00001
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 18, 2019
    Manufacturer
    PUREGRAFT LLC
    Product Code
    MUU
    PMA / PMN Number
    K113255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE (600-014-02), INCLUDES INSTRUCTIONS ON HOW TO OPERATE THE PRODUCT. ACCORDING TO TABLE 1, DRAIN TIME IS APPROXIMATELY 2-6 MINUTES, DEPENDING ON THE INPUT VOLUME. IT IS NOT KNOWN WHETHER THE CLINICIAN FOLLOWED INSTRUCTIONS IN THE IFU. IT IS ALSO UNKNOWN WHETHER THE CLINICIAN OPENED THE PINCH CLAMP TO ALLOW SUCCESSFUL DRAINING. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. PHOTOS WERE NOT PROVIDED. PUREGRAFT PERSONNEL CONDUCTED IN-HOUSE TESTING TO SIMULATE DRAIN FAILURE. THE FAILURE COULD NOT BE REPLICATED. PUREGRAFT PERSONNEL ALSO KINKED THE TUBING; HOWEVER, DRAINING WAS STILL SUCCESSFUL AFTER KINKING TUBING AND THE FAILURE COULD NOT BE REPLICATED. THE LOT HISTORY DOCUMENTATION WAS REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. PUREGRAFT WILL CONTINUE TO MONITOR FOR RECURRENCE.

    Description of Event or Problem · 1

    DURING BREAST LIPOSTRUCTURE SURGERY, THE PUREGRAFT BAG 850CC DOES NOT OR VERY LITTLE FILTER THE INFILTRATION FLUID, WHICH LED TO THE NECESSITY OF FAT EXTRACTION AND CENTRIFUGATION OF A PART OF THE POCKET. THIS RESULTED IN DIFFICULTY IN TAKING THE FAT OUT OF THE POCKET. THIS LED TO EXTENSION OF SURGERY TIME OF 1H20, PATIENT HAD HYPOTHERMIA AT 35.5°C DURING SURGERY, WHICH INCREASED POST-OPERATIVE RISK. PRECAUTIONARY MEASURES WERE TAKEN: STRICT ASEPSIS AND ANTIBIOPROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366675 PUREGRAFT 850 SYSTEM SYSTEM, SUCTION, LIPOPLASTY MUU PUREGRAFT LLC 101-014-02 00052114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention