BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLIENT SORBENT HEMODIALYSIS SYSTEM

    MDR report key: 1061871 · Received June 13, 2008

    Report

    Report Number
    MW5007342
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    April 25, 2008
    Report Date
    June 13, 2008
    Manufacturer
    RENAL SOLUTIONS
    Product Code
    KDI
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT RECEIVED IN 2008, INDICATED THAT A PT HAD INCORRECTLY SET-UP THE DEVICE BY INSTALLING THE INFUSATE TUBING INCORRECTLY. DURING PRE-TREATMENT AND TREATMENT, THE DEVICE ALARMED MULTIPLE TIMES FOR AN "INFUSATE TOO SLOW/TOO FAST" CONDITION. THE PT ATTEMPTED TO CLEAR THE ALARMS FOR AN EXTENDED PERIOD OF TIME UNTIL HE BECAME AWARE THAT THE INFUSATE LINES WERE CONNECTED INCORRECTLY - THE DEVICE LOG INDICATED THAT THE PT HAD CLEARED THE ALARMS 90 TIMES OVER A 2 HOUR PERIOD. THERE WAS NO REPORTED PT HARM. IF THIS SITUATION WERE TO RECUR, THE PROBABILITY OF LEADING TO SERIOUS INJURY OR DEATH IS GREATER THAN REMOTE, THEREFORE, CATEGORIZING IT AS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIENT SORBENT HEMODIALYSIS SYSTEM HEMODIALYSIS SYSTEM KDI RENAL SOLUTIONS 1100

    Patients

    Seq Age Sex Outcome Treatment
    1