BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 6173228 · Received December 14, 2016

    Report

    Report Number
    1219343-2016-00088
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 17, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    GKT
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HAEMONETICS FILED SERVICE ENGINEER EVALUATED THE DEVICE. THE DEVICE WAS RUN THROUGH DIAGNOSTICS AND MEETS ALL MANUFACTURER SPECIFICATIONS. THERE WAS NO DEVICE ISSUE IDENTIFIED. THE DEVICE WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED NOTIFICATION FROM A CUSTOMER ON 11/17/2016 THAT DURING A ROUTINE PLASMAPHERESIS, A DONOR EXPERIENCE A SEIZURE. THE DONOR BEGAN SWEATING AND WAS FEELING WARM AND DIZZY. THE DONOR THEN BEGAN SEIZING/CONVULSING WITH VOMITING. THE DONATION WAS DISCONTINUED AT THAT TIME WITH 800ML OF PLASMA COLLECTED. THE DONOR DID NOT RECEIVE THE 500ML OF SALINE WHICH NORMALLY WOULD HAVE BEEN ADMINISTERED. EMS WAS CALLED AND THE DONOR WAS TRANSPORTED TO A LOCAL EMERGENCY ROOM. FOLLOW UP WITH THE DONOR DETERMINED THAT IV FLUIDS WERE GIVEN AND THEN THE DONOR WAS DISCHARGED A FEW HOURS LATER FROM THE EMERGENCY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824468 PCS®2 PLASMA COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT HAEMONETICS CORP 06002-110-EXP-EW

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other