BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS + 8150

    MDR report key: 2921886 · Received January 15, 2013

    Report

    Report Number
    1219343-2013-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK090004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE TECHNICIAN EVALUATED THE MACHINE. ALL TEST PARAMETERS PASSED MANUFACTURER'S SPECIFICATIONS. THE DATA DOWNLOAD OF THE DEVICE SHOWED A COUPLE OF WEIGHER WARNINGS TO THE OPERATOR AND FLOW PROBLEMS THAT THE SOFTWARE SELF-REGULATED FOR DURING THE PROCEDURE. THE MANUAL STOPPING OF THE PROCEDURE DID NOT ALLOW FOR THE RETURN OF THE PLASMA. THIS ACCOUNTED FOR VOLUME LOSS TO THE DONOR. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2013, TO REPORT A PCS2 DEVICE WITH DESCRIPTION "CUSTOMER BELIEVES THAT ECV MAY HAVE BEEN REACHED WITHOUT AN ALARM AND WOULD LIKE TO HAVE DATA DOWNLOADED AND INTERPRETED TO DETERMINE WHAT OCCURRED. HAEMONETICS PRODUCT SUPPORT RECEIVED INFORMATION THAT THE DONOR WENT TO THE HOSPITAL." DURING THE PROCESS OF A DOUBLE RED CELL DONATION, THE OPERATOR STOPPED THE PROCEDURE WHEN IT WAS NOTICED THAT A LARGER THAN NORMAL VOLUME OF PLASMA WAS IN THE BAG. THE FIRST CYCLE COMPLETED WITH NO ISSUES NOTED. BY STOPPING THE PROCEDURE, THE RED CELLS WERE TRANSFERRED TO THE COLLECTION BAGS, BUT APPROXIMATELY 672ML OF PLASMA WAS RETAINED. ONLY 155ML OF SALINE RETURNED. THE DONOR REPORTED FEELING LIGHT-HEADED AND THEN EXPERIENCED A BRIEF LOSS OF CONSCIOUSNESS FOLLOWED BY VOMITING. WHILE BEING MONITORED, THE SYMPTOMS RETURNED AND THE DONOR WAS TRANSPORTED VIA AMBULANCE TO THE LOCAL HOSPITAL. THE DONOR WAS ADMITTED, TREATED WITH I.V. FLUIDS AND RELEASED LATER THAT SAME DAY. THE BLOOD CENTER CONTACTED THE DONOR ON (B)(4) 2013, WHO STATED FEELING BETTER AND BACK AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22575 MCS + 8150 GKT HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization