BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11812255 · Received May 12, 2021

    Report

    Report Number
    1219343-2021-00068
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    September 30, 2019
    Report Date
    September 30, 2019
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT AS PART OF A SERVICE RECORD RETROSPECTIVE REVIEW THAT WAS SELF IDENTIFIED BY HAEMONETICS. CUSTOMER BIOMED WAS PROVIDED WITH PART FOR REPAIR: THE SUSPECT DEVICE/PART WAS NOT RETURNED TO HAEMONETICS, WITHOUT PHYSICAL SAMPLE PROVIDED FOR EVALUATION, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED "CPU CARD WITH REV K - 176543-00 AS ITS BURNT OUT BLACK ALL OUT. POWER SUPPLY (CONDOR) - 84210-10 AS ITS READING HIGH VOLTAGES." THERE WAS NO DONOR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709520 NEXSYS PCS SYSTEM NEXSYS PCS, US, PRODUCT CODE: GKT GKT HAEMONETICS CORPORATION NEXSYS PCS SYSTEM 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1