BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 3952696 · Received July 17, 2014

    Report

    Report Number
    2523676-2014-00282
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 20, 2014
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ORIGINAL REPORT: AS REPORTED BY THE USER FACILITY: CUSTOMER STATED THAT THEY HAD A PATIENT THAT CONTRACTED (B)(6) AND HE WANTED MORE INFORMATION ABOUT THE MACHINE BECAUSE HE WAS NOT AS FAMILIAR WITH THE DIALOG + MACHINE. CUSTOMER STATED THAT HE DOES NOT BELIEVE THAT THE MACHINE CONTRIBUTED TO THE TRANSFER BUT WANTED TO DISCUSS THE POSSIBILITY. AFTER A FOLLOW UP TELEPHONE CALL WITH THE FACILITY ON (B)(4) 2014, B BRAUN (B)(4) LEARNED THAT TWO PATIENTS WERE DIAGNOSED WITH (B)(6) IN (B)(6) 2014. ACCORDING TO THE FACILITY, BOTH PATIENTS WERE INFECTED WITH THE DISEASE MOST PROBABLY IN (B)(6) 2014. THE TWO PATIENTS WERE TREATED ON THE SAME DIALOG+ DIALYSIS MACHINE AFTER A PATIENT SUFFERING FROM (B)(6) HAD BEEN TREATED. MFR - 3002879653-2014-00282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420200 DIALOG A + HE/BIC HEMODIALYSIS SYSTEM KDI B. BRAUN AVITUM AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK