BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A+HE/BIC

    MDR report key: 2974108 · Received February 15, 2013

    Report

    Report Number
    3002879653-2013-00021
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    PMA / PMN Number
    K963440
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). (B)(6). (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT #(B)(4). IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER STATED THAT A STAFF CALL WAS MADE BY THE PT A COUPLE OF HOURS INTO THE RUN BECAUSE HE WAS FEELING LIGHT HEADED WHILE CONNECTED TO THE MACHINE. THE NURSE CAME OVER AND DISCONNECTED THE PT. WHEN THE PT WAS DISCONNECTED, THE PT PASSED OUT AND BECAME NON-RESPONSIVE. THE PT WAS TAKEN TO THE ER. THE PT'S LEVEL WERE STABILIZED AND THE PT WAS RELEASED THE SAME DAY. THE REPORTER ALSO STATED THAT THE MACHINE OPERATED AS INTENDED. THE TREND FILES FOR THE ACTUAL DEVICE ARE BEING SENT AND THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PT CRASHED AND WAS HOSPITALIZED IN ER AND RELEASED AFTER A VENOUS PULL. TREND OF THERAPY IS BEING SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69397 DIALOG A+HE/BIC HEMODIALYSIS SYSTEM KDI B. BRAUN AVITUM AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other