BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIALOG PLUS

    MDR report key: 2082629 · Received April 28, 2011

    Report

    Report Number
    2523676-2011-00046
    Event Type
    Other
    Date Received
    April 28, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KDI
    PMA / PMN Number
    K963440
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THE PT'S HEALTH HAD BEEN DETERIORATING PRIOR TO TREATMENT AND THE STAFF DOES NOT FEEL THE MACHINE HAD ANYTHING TO DO WITH THE PT'S DEATH. HOWEVER, THE CUSTOMER HAS REQUESTED THAT A B. BRAUN CUSTOMER ENGINEER DO A FUNCTIONAL CHECK OF THE MACHINE BEFORE THE MACHINE IS RETURNED TO OPERATION. A B. BRAUN CUSTOMER ENGINEER PERFORMED A FUNCTIONAL CHECK OF THE MACHINE AND FOUND NO ISSUES WITH THE MACHINE. A TREND FILE WAS TAKEN FROM THE MACHINE. THE MACHINE HAS BEEN PUT BACK INTO OPERATION. A BATCH REVIEW WAS PERFORMED BY REVIEWING THE INCOMING CERTIFICATE AND IT WAS VERIFIED THAT THE DEVICE COMPLIED WITH THE SPECIFICATIONS UPON RECEIPT. ALL AVAILABLE INFORMATION AND THE TREND FILE HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER FOR EVALUATION. IF ANY PERTINENT INFORMATION BECOMES AVAILABLE THROUGH THE TREND FILE EVALUATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PT'S DIALYSIS TREATMENT WAS ENDED EARLY AND PT REMOVED FROM THE MACHINE. SHORTLY AFTER BEING REMOVED THE PT DIED. THE TREATMENT WAS ENDED EARLY DUE TO THE PT NOT FEELING WELL. THE PT'S HEALTH HAD BEEN DETERIORATING PRIOR TO TREATMENT AND THE STAFF DOES NOT FEEL THE MACHINE HAD ANYTHING TO DO WITH THE PT'S DEATH. CUSTOMER HAS REQUESTED THAT A B. BRAUN CUSTOMER ENGINEER DO A FUNCTIONAL CHECK OF THE MACHINE BEFORE THE MACHINE IS RETURNED TO OPERATION. THE CAUSE OF DEATH WAS UNK AT THE TIME OF THE CALL. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE EXACT CAUSE OF DEATH IS UNK TO THEM, HOWEVER THE FACILITY IS 99.99% CONFIDENT THAT THE MACHINE HAD NOTHING TO DO WITH THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALOG PLUS HEMODIALYSIS SYSTEM KDI B. BRAUN MEDICAL INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death