BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3021316 · Received March 19, 2013

    Report

    Report Number
    3021316
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 19, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    MQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    HEMODIALYSIS STARTED AT 0920. AT 0925 THE MACHINE INDICATED DIAL VALVE FAILURE 1 AND MACHINE WENT INTO BYPASS. PATIENT NOT RINSED BACK. MD IN ROOM. H&H DRAWN - NEW TUBING AND MACHINE SET UP. HD COMPLETED. PATIENT DISCHARGED. DISCUSSED WITH COMPANY REPRESENTATIVE. TEST RUN - COULD NOT DUPLICATE ALARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEMODYALISIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113460 * SYSTEM, HEMODIALYSIS MQS FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR DIALYSIS