BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11812256 · Received May 12, 2021

    Report

    Report Number
    1219343-2021-00078
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    November 27, 2019
    Report Date
    November 27, 2019
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: POWER ENTRY MODULE ASSEMBLY, FUSE FAST ACTING(1/4DIAX1-1/4L, POWER SUPPLY, SL POWER, ROHS. 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 PATIENT REPORTED, "POWER SUPPLY/SHORTING/BURNT OUT POWER ENTRY MODULE/SMOKE/BURNT FUSE". THERE WAS NO DONOR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709521 NEXSYS PCS SYSTEM NEXSYS PCS, US, PRODUCT CODE: GKT GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1