BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 11609351 · Received April 2, 2021

    Report

    Report Number
    1219343-2021-00106
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 4, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011956
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE PCS®2 PLASMA COLLECTION SYSTEM. A DUROMETER TEST WAS CARRIED OUT; BLOOD PUMP AND AC PUMP ROTORS WERE CONFIRMED FUNCTIONAL, CLEANED AND READY FOR USE. THE CENTRIFUGE WAS ALSO CHECKED AND ALL FUNCTIONAL TESTS PASSED ON THE EQUIPMENT. HAEMONETICS FIELD SERVICE ENGINEER FOUND NO ISSUES AND UNIT MET MANUFACTURERS SPECIFICATIONS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF HIGHER RETURN PRESSURE WHICH OCCURRED AT THE END OF A DONATION IN (B)(4), UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE DONATION WAS STOPPED DUE TO THE BLOOD IN THE TUBE BEING VISCOUS. SHORTLY AFTER PROCEDURE WAS STOPPED OPERATOR NOTICED THAT THE COLLECTED PLASMA OF APPROX. 230ML WAS CLOTTED. DONOR WAS SENT TO THE HOSPITAL AND WAS RELEASED THE SAME DAY, THERE WERE NO ABNORMAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504696 PCS2 PLASMA COLLECTION SYSTEM PCS2, LIST NO. 06002-220-EXP GKT HAEMONETICS CORPORATION 06002-220-EXP 30812747011956

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention