BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 12878166 · Received November 26, 2021

    Report

    Report Number
    1219343-2021-00145
    Event Type
    Death
    Date Received
    November 26, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 26, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK040025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DONOR'S AUTOPSY REPORT AND ANY FOLLOW-UP CLINICAL INFORMATION IS NOT AVAILABLE. A HAEMONETICS FIELD SERVICE ENGINEER WAS DISPATCHED TO INSPECT THE PCS®2 PLASMA COLLECTION SYSTEM. THE FIELD SERVICE ENGINEER RAN A FUNCTIONAL TEST AND DETERMINED THE DEVICE MET MANUFACTURER SPECIFICATIONS. THERE WERE NO ISSUES, EVENTS OR ALARMS NOTED WITH THE SYSTEM USED DURING THE PROCEDURE AND THERE WERE NO ISUES NOTED WITHT THE DISPOSABLES. THE SAME PCS 2 SYSTEM WAS USED AFTER THE EVENT AND WAS REPORTED TO HAVE FUNCTIONED NORMALLY. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, THEREFORE COULD NOT BE EVALUATED BY HAEMONETICS, HOWEVER, THERE WERE NO RECALLS OR ADVERSE TRENDS REPORTED AGAINST THE 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)(6) 2021, HAEMONETICS WAS MADE AWARE OF A DONOR DEATH SHORTLY AFTER A DONATION PROCEDURE UTILIZING A PCS@2 COLLECTION SYSTEM. THE DONOR WAS A (B)(6) MALE WITH A HISTORY OF HIGH BLOOD PRESSURE; IT IS UNKNOWN IF ANY MEDICATION WAS TAKEN WITHIN 72 HOURS OF DONATION. DONOR COMPLETED SUCCESSFUL DONATION ON (B)(6) 2021 AND WAS COMPLICATION FREE THROUGHOUT THE PROCEDURE. DONOR REPORTEDLY WENT HOME AFTER DONATION AND SUFFERED A HEART ATTACH APPROXIMATELY 30 MINUTES AFTER ARRIVING HOME. EMS WAS CALLED. DONOR PASSED. DONOR'S COHABITANT CALLED AND REPORTED DEATH OF DONOR TO THE CENTER ON (B)(6), 2021. DONOR CENTER INVESTIGATION POST REPORTING DISCOVERED THERE WERE NO ERRORS ON THE MACHINE AT THE TIME OF USE. THERE WERE NO ISSUES SEEN WITH ANY OF THE DISPOSABLES AT THE TIME OF USE. DONATION WAS WITHOUT ANY NOTED COMPLICATION. THE PCS2 SYSTEM WAS REMOVED FROM SERVICE AND PLACED INTO QUARANTINE ONCE THE INCIDENT WAS REPORTED TO THE CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776606 PCS®2 PLASMA COLLECTION SYSTEM PCS2,LIST NO,LN06002-110-EXP-EW GKT HAEMONETICS CORPORATION 06002-110-EXP-EW

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death