BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS+

    MDR report key: 2220032 · Received August 9, 2011

    Report

    Report Number
    1219343-2011-00117
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    May 14, 2011
    Report Date
    August 9, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(4) 2011 ALLEGING THAT A HIGH PRESSURE WARNING OCCURRED DURING THE 2ND DRAW ON THE MCS+ 9000. THE PROCEDURE WAS CONTINUED AFTER VERIFYING KIT SET UP. NEAR THE END OF THE 3RD DRAW, THE FLOW STOPPED AND THE PROCEDURE WAS THEN DISCONTINUED. CLOTS WERE FOUND IN THE BOWL AND PLASMA BAG. NO DONOR INJURY REPORTED. NO OPERATOR INJURY REPORTED. INVESTIGATION IS ONGOING. F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 ALLEGING THAT A HIGH PRESSURE WARNING OCCURRED DURING THE 2ND DRAW ON THE MCS+ 9000. THE PROCEDURE WAS CONTINUED AFTER VERIFYING KIT SET UP. NEAR THE END OF THE 3RD DRAW, THE FLOW STOPPED AND THE PROCEDURE WAS THEN DISCONTINUED. CLOTS WERE FOUND IN THE BOWL AND PLASMA BAG. NO DONOR INJURY REPORTED. NO OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCS+ LN9000 AUTOMATED BLOOD CELL SEPARATOR GKT HAEMONETICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI