BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS+8150

    MDR report key: 2220051 · Received August 9, 2011

    Report

    Report Number
    1219343-2011-00116
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 9, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK090004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND ALLEGED THAT THEY RECEIVED W36 ALARM (PLASMA WEIGHT NOT DECREASING) AND AN INTERMITTENT DISPLAY ON THE BEGINNING OF THE SECOND RETURN ON THE LN8150. THE OPERATOR NOTICED A MASS HAD FORMED INTO THE RED CELL BAG AND THE PLASMA WAS THICK AND FOAMY. UPON REMOVING THE KIT, THEY ALSO NOTED A CLOT IN THE BOWL. NO DONOR INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED IN THE FIELD BY HAEMONETICS ON (B)(6) 2011. THE FIELD SERVICE ENGINEER FOUND THE DEVICE TO BE WORKING ACCORDING TO PERFORMANCE SPECS. THE CONTROL PANEL COMMUNICATION CABLE WAS REPLACED AS A PRECAUTION FOR THE FLICKERING DISPLAY. DISPOSABLE SAMPLE OF THE KIT USED WAS RETURNED AND IS UNDER INVESTIGATION. NO ISSUES WERE FOUND DURING THE HISTORICAL REVIEWS OF THE DISPOSABLES OR SOLUTIONS USED. F/U REPORT WILL BE FILED ONCE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND ALLEGED THAT THEY RECEIVED W36 ALARM (PLASMA WEIGHT NOT DECREASING) AND AN INTERMITTENT DISPLAY ON THE BEGINNING OF THE SECOND RETURN ON THE LN8150. THE OPERATOR NOTICED A MASS HAD FORMED INTO THE RED CELL BAG AND THE PLASMA WAS THICK AND FOAMY. UPON REMOVING THE KIT, THEY ALSO NOTED A CLOT IN THE BOWL. NO DONOR INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCS+8150 LN8150 AUTOMATED BLOOD CELL SEPARATOR GKT HAEMONETICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI