BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 12802841 · Received November 12, 2021

    Report

    Report Number
    1219343-2021-00140
    Event Type
    Death
    Date Received
    November 12, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 12, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DONATION CENTER WAS NOTIFIED OF DEATH BY THE DONOR'S WIFE. THE CAUSE OF DEATH WAS A HEART ATTACK SUFFERED AT HIS HOME. THE CENTER HAS NOT RECEIVED THE AUTOPSY REPORT AND NO FURTHER REQUEST FROM THE CENTER WILL BE MADE. HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE NEXSYS PLASMA COLLECTION SYSTEM. THE UNIT WAS INSPECTED AND CALIBRATION TESTS WERE PERFORMED. NO ISSUES WERE DETECTED WITH DEVICE CALIBRATION AND CONFIGURATION. THE DEVICE PASSED THE FUNCTION TEST AND MET MANUFACTURER'S SPECIFICATIONS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND. 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 USED DURING THE PLASMAPHERESIS PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(4) 2021, HAEMOETICS WAS NOTIFIED OF A DONOR FATALITY ON (B)(6) 2021 DUE TO A HEART ATTACK WHILE AT HIS HOME. THE LAST DONATION UTILIZING THE NEXSYS PLASMA COLLECTION SYSTEM OCCURRED ON (B)(6) 2021. DONOR HAS DONATED PLASMA SINCE (B)(6) 2015. DONOR HAS DONATED 48 TIMES THIS YEAR AND TWICE IN (B)(6) 2021. NO SIGNIFICANT INFORMATION OR ABNORMAL MEDICAL ISSUES WERE NOTED ON LAST DATE OF DONATION. REVIEW OF CHART NOTED HISTORY OF A NORMAL PHYSICAL EXAM. ALL LAB RESULTS WERE NORMAL EXCEPT FOR 5 FAILED TESTS FOR SERUM PROTEIN ELECTROPHORESIS. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION, HOWEVER DONOR WAS NOTED TO HAVE 5 OUT OF LIMIT VITAL SIGNS WITHIN THE PAST 2 YEARS. RECORD REVIEW NOTED NO SIGNIFICANT PAST MEDICAL HISTORY OR OTHER SIGNIFICANT MEDICAL INFORMATION. THE DONOR REPORTED HE WAS NOT ON ANY MEDICATIONS. TEMPORARY DEFERRALS WERE PLACED FOR OUT OF LIMIT VITAL SIGNS AND FAILED SERUM PROTEIN ELECTROPHORESIS. THE LAST PLASMA DONATION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 749 ML OF PURE PLASMA COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702705 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death