BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11812233 · Received May 12, 2021

    Report

    Report Number
    1219343-2021-00043
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    September 4, 2018
    Report Date
    September 4, 2018
    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. THE FOLLOWING PARTS WERE SENT TO CUSTOMER BIOMED FOR REPAIR: PCB,ASSY,DSP DST,PCS2,8150,ACP. 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 THE CUSTOMER REPORTED A BURNT CENTRIFUGE DISTRIBUTION BOARD. CUSTOMER ALSO REQUESTS PUMP TUBE GUIDE AND FLUID SENSOR AS THE SCREWS ARE MISSING. THERE WAS NO DONOR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708903 NEXSYS PCS SYSTEM NEXSYS PCS, US, PRODUCT CODE: GKT GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1