BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALOG+

    MDR report key: 10454479 · Received August 26, 2020

    Report

    Report Number
    3002879653-2020-00005
    Event Type
    Death
    Date Received
    August 26, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 9, 2020
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    KDI
    UDI-DI
    04046964285608
    PMA / PMN Number
    K083460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE CUSTOMER TECHNICIAN STATED THAT HE VERIFIED ALL THE MACHINE SAFETY CALIBRATIONS AND THAT AT THE TIME OF THE INCIDENT THE MACHINE WAS OPERATING WITHIN B. BRAUN SPECIFIED LIMITS AND TOLERANCES. THE INVESTIGATION AND EVALUATION OF THE DATA SOURCES MADE AVAILABLE BY THE CUSTOMER LEADS TO THE CONCLUSION THERE WAS NO PRODUCT DEVIATION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: BIO-MED REPORTED A PATIENT CODED AND PASSED AWAY DURING A TREATMENT. BIO-MED VERIFIED ALL THE MACHINE SAFETY CALIBRATIONS AND AT THE TIME OF THE INCIDENT THE DIALOG MACHINE WAS OPERATING WITHIN SPECIFIED LIMITS AND TOLERANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920951 DIALOG+ DIALYZER, HIGH PERMEABILIT KDI B. BRAUN AVITUM AG - MELSUNGEN 710200S 04046964285608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other