BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 2340166 · Received November 11, 2011

    Report

    Report Number
    3004548776-2011-00003
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    September 27, 2011
    Report Date
    October 14, 2011
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT INVOLVED WAS EVALUATED AND REMAINED IN USE BETWEEN THE TIME OF THE INCIDENT AND WHEN FENWAL WAS NOTIFIED OF THE REPORTED EVENT. THE INSTRUMENT HISTORY WAS DOWNLOADED AND REVIEWED, HOWEVER, DO THE LENGTH OF TIME BETWEEN THE EVENT AND THE REPORT THE SPECIFIC DETAILS OF THE PROCEDURE WERE NOT AVAILABLE. THE AMICUS KIT THAT WAS USED DURING THE PROCEDURE WAS DISCARDED AND NO LOT AND UNABLE TO BE EVALUATED. FENWAL IS CONTINUING TO INVESTIGATE THE EVENT TO DETERMINE A POSSIBLE CAUSE AND WILL SUBMIT F/U WITH ANY ADD'L DETAILS. (B)(4).

    Description of Event or Problem · 1

    AN INITIAL REPORT OF A SEVERE REACTION WITH TETANY WHILE DONATING PLATELETS ON AN AMICUS MACHINE WAS RECEIVED ON (B)(6) 2011. THE USER FACILITY INDICATED THAT THE DONOR WAS SENT TO THE HOSPITAL. THE DONATION TOOK PLACE ON (B)(6) 2011. THE FACILITY INDICATED THAT THE DONOR MIGHT HAVE HAD A STROKE OR A POSSIBLE AIR EMBOLISM. ON (B)(6) 2011, ADD'L DETAILS WERE RECEIVED AND THE USER FACILITY INDICATED THAT THERE WERE NO SIGNS OR INDICATIONS FROM THE PT OF DISCOMFORT FROM THE CITRATE. THE DONOR SUDDENLY GROANED AND BEGAN TO SEIZE. THE TECHS ON THE FLOOR GRABBED HIS ARMS TO KEEP THEM STRAIGHT. 911 WAS CALLED AND PARAMEDICS INDICATED HE HAD A STROKE. HIS RIGHT SIDE WAS PARALYZED AND HE WAS UNABLE TO SPEAK UPON DEPARTURE TO THE HOSP. PT RETURNED TO THE CENTER A FEW DAYS LATER FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATOR GKT FENWAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention