BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GPSIII 30 W/ACDA JP

    MDR report key: 7876424 · Received September 14, 2018

    Report

    Report Number
    0001825034-2018-08894
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 15, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KSS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER BK070026.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE BLOOD INSIDE THE KIT IS BLACK. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE GPS WAS PUT THROUGH THE CYCLE IN THE CENTRIFUGE, THE PATIENT'S BLOOD WOULD NOT PROPERLY SEPARATE. ADDITIONAL BLOOD HAD TO BE DRAWN FROM THE PATIENT DUE TO THE MALFUNCTION.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718282 GPSIII 30 W/ACDA JP SUPPLIES, BLOOD BANK KSS ZIMMER BIOMET, INC. N/A 602372

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention