BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 16513802 · Received March 9, 2023

    Report

    Report Number
    1219343-2023-00007
    Event Type
    Death
    Date Received
    March 9, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 9, 2023
    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

    A WORK ORDER WAS INITIATED BY THE CENTER THAT HAD THE FOLLOWING PROBLEM DESCRIPTION: "DONOR FATALITY THE DAY AFTER DONATION POSSIBLY DUE TO DRUG USE. DEVICE DID NOT FAIL DURING PROCEDURE ACCORDING TO STAFF. REQUIRE VERIFICATION FROM HAE FSE TO PUT BACK INTO SERVICE." A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE NEXSYS PCS SYSTEM USED DURING THE (B)(6) 2023 DONATION. THE UNIT WAS CALIBRATED AND ALL DIAGNOSTICS PERFORMED. THE UNIT WAS FOUND IN GOOD WORKING ORDER AND MET MANUFACTURING SPECIFICATIONS. THERE ARE NO NONCONFORMANCES AGAINST THE DEVICE SERIAL NUMBER AND NO CAPAS RELATED TO THIS COMPLAINT. A REVIEW OF THE DHR SHOWS NO ISSUES DURING MANUFACTURING AND ALL TESTING PASSED. THE DISPOSABLES USED WITH THE SYSTEM WERE DISCARDED, 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) 2023, HAEMONETICS WAS NOTIFIED THAT A 40-YEAR OLD FEMALE DONOR EXPIRED AT HER APARTMENT ON (B)(6) 2023 FROM AN UNKNOWN CAUSE. THE CENTER OBTAINED THIS INFORMATION FROM A SOCIAL MEDIA POST. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED OR IF THE REPORT WILL BE MADE AVAILABLE. THE CENTER HAS NO INFORMATION REGARDING HOSPITALIZATION OF THE DECEASED. DONOR HAS DONATED PLASMA SINCE (B)(6), 2022, SIX TIMES THIS YEAR AND 40 TIMES IN A LIFETIME. DONOR'S LAST DONATION WAS (B)(6) 2023 AND NO SIGNIFICANT INFORMATION WAS NOTED DURING THAT DONATION. REVIEW OF CHART NOTED HISTORY OF A NORMAL PHYSICAL EXAM, NORMAL LABS, AND TEST RESULTS. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION. THERE IS NO RECORD OF ANY ISSUES WITH THE NEXSYS PCS SYSTEM OR DISPOSABLES USED DURING THE DONATION ON (B)(6) 2023. NO FURTHER INFORMATION FROM THE CENTER IS EXPECTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63215 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Death