BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 13528521 · Received February 14, 2022

    Report

    Report Number
    1219343-2022-00009
    Event Type
    Death
    Date Received
    February 14, 2022
    Date of Event
    January 15, 2022
    Report Date
    January 31, 2022
    Manufacturer
    HAEMONETICS, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS DONOR FATALITY DUE TO DUE TO A PITUITARY TUMOR AS INDICATED BY HIS WIFE. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION IS EXPECTED FROM THE REPORTER. THE STATUS OF THE DISPOSABLES USED IN THE DONATION IS UNKNOWN. ON (B)(6) 2022, THE NEXSYS SYSTEM WAS EVALUATED BY A HAEMONETICS FIELD SERVICE ENGINEER. CALIBRATION, DIAGNOSTICS AND FUNCTIONAL TESTING WAS PERFORMED AND ALL PASSED. THE MACHINE WAS FOUND TO MEET MANUFACTURER SPECIFICATIONS AND READY FOR USE. THERE WERE NO RECALLS OR ADVERSE TRENDS RELATED TO THE DISPOSABLE LOTS USED IN THE DONATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE DONOR FATALITY WAS RELATED TO THE DEVICE OR DISPOSABLES USED DURING THE PLASMAPHERESIS PROCEDURE.

    Description of Event or Problem · 0

    ON JANUARY 31, 2022, HAEMONETICS WAS NOTIFIED OF A (B)(6)-YEAR-OLD MALE DONOR FATALITY ON (B)(6) 2022 DUE TO A PITUITARY TUMOR AS INDICATED BY HIS WIFE. THE LAST DONATION UTILIZING THE NEXSYS PLASMA COLLECTION SYSTEM OCCURRED ON (B)(6) 2022. DONOR HAS DONATED PLASMA SINCE (B)(6) 2019. HE HAS DONATED 4 TIMES IN THE PAST MONTH AND 135 TIMES IN TOTAL. NO SIGNIFICANT INFORMATION OR CONCERNS WERE NOTED ON THE DATE OF HIS LAST DONATION. REVIEW OF CHART NOTED HISTORY OF A NORMAL PHYSICAL EXAM ((B)(6) 2021), LABS AND TESTS RESULTS ((B)(6) 2022). THERE WAS NO HISTORY OF MEDICAL PROBLEMS AND DONOR WAS NOT ON ANY MEDICATIONS. THERE WAS ALSO NO DOCUMENTATION OF MEDICAL CONCERNS IN THE NOTES. REVIEW OF VITALS WAS NORMAL ON DATE OF LAST DONATION HOWEVER, DONOR WAS NOTED TO HAVE ONE OUT OF LIMIT PULSE (111, (B)(6) 2022) AND 3 OUT OF LIMIT TEMPERATURES (99.8 F ON (B)(6) 2019, 99.8 F ON (B)(6) 2019, AND 100.1 F ON (B)(6) 2022). DEFERRALS WERE NOTED DUE TO OUT OF LIMIT PULSE AND TEMPERATURES, LAPSED DONOR AND TEMPORARY MEDICAL. THE TEMPORARY MEDICAL DEFERRAL WAS DUE TO A SERUM PROTEIN ELECTROPHORESIS (SPE) THAT WAS FAILED IN ERROR. THERE WERE NO MEDICAL INCIDENT REPORTS DURING HIS TIME DONATING. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED OR IF A MEDICAL EXAMINER REPORT WILL BE AVAILABLE. THERE WERE NO DEVICE ERRORS OR ISSUES WITH THE DISPOSABLES NOTED DURING THE DONATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559108 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS, INC. PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Death