BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 13938046 · Received March 29, 2022

    Report

    Report Number
    1219343-2022-00018
    Event Type
    Death
    Date Received
    March 29, 2022
    Date of Event
    February 13, 2022
    Report Date
    March 18, 2022
    Manufacturer
    HAEMONETICS, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS DONOR FATALITY DUE TO A SUSPECTED HEART ATTACK. NO FURTHER INFORMATION IS EXPECTED FROM THE REPORTER. 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. THE DEVICE WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS, NON-CONFORMANCES OR CAPAS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE STATUS OF THE DISPOSABLES USED WITH THE SYSTEM IS UNKNOWN, HOWEVER THERE WERE NO RECALLS OR ADVERSE TRENDS RELATED TO THE PRODUCT LOTS USED IN THE PROCEDURE. 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 (B)(6) 2022, HAEMONETICS WAS NOTIFIED OF A (B)(6) MALE DONOR FATALITY ON (B)(6) 2022 DUE TO A POSSIBLE HEART ATTACK AT HIS HOME. THE LAST DONATION UTILIZING THE NEXSYS PLASMA COLLECTION SYSTEM OCCURRED ON (B)(6) 2022. DONOR HAS DONATED PLASMA SINCE (B)(6) 2020. HE HAS DONATED 96 TIMES IN THE PAST 24 MONTHS AND 96 TIMES IN TOTAL. NO SIGNIFICANT INFORMATION WAS NOTED ON LAST DATE OF DONATION. THE CHART REVIEW NOTED NO SIGNIFICANT PAST MEDICAL HISTORY AND NORMAL PHYSICAL EXAMINATION, LABORATORY AND TEST RESULTS. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION. HOWEVER, DONOR WAS NOTED TO HAVE 3 OUT OF LIMIT TEMPERATURES (99.7, 99.9, 100.0 F) DURING HIS TIME AT OCTAPHARMA PLASMA, INC. NO OTHER SIGNIFICANT MEDICAL INFORMATION WAS NOTED IN THE DONOR RECORD 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
    646906 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS, INC. PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Death