BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 280562 · Received May 24, 2000

    Report

    Report Number
    280562
    Event Type
    Injury
    Date Received
    May 24, 2000
    Date of Event
    April 15, 2000
    Report Date
    April 18, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT'S VENOUS LINE BECAME DISCONNECTED FROM THE TESIO CATHETER DURING HEMODIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEMODIALYSIS VENOUS LINE FKJ FRESENIUS USA 7303 9PR131

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening RECEIVED HEMODIALYSIS TREATMENT THREE TIMES A| WEEK.