BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11812251 · Received May 12, 2021

    Report

    Report Number
    1219343-2021-00071
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    October 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE FIELD SERVICE TECHNICIAN REPORTED, REPLACED CARRIER AND RIBBON CABLES. RAN CALIBRATIONS AND VERIFICATION. RAN LEVEL 1 & 2 QC AND VERIFIED THAT THE DEVICE RUNS ACCORDING TO MANUFACTURERS SPECIFICATIONS. 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 , "CENTRIFUGE DISTRIBUTION PCB ASSY - 35215-10 AS THE BOARD IS BURNT. PUMP ROTOR ASSEMBLY - 38671-00, 37041-00 & 37040-00 AS THEY ARE BLACK AND STICKEY". THERE WAS NO DONOR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709515 NEXSYS PCS SYSTEM NEXSYS PCS, US, PRODUCT CODE: GKT GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1