BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 2010482 · Received March 1, 2011

    Report

    Report Number
    2937457-2011-00003
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 1, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION WAS PERFORMED BY THE MFR AND THE MACHINE WAS FOUND TO BE WITHIN SPECIFICATIONS. THERE WAS NO ULTRAFILTRATION ERROR FOUND. THE MOST LIKELY CAUSE OF THE EVENT IS THAT THE UF GOAL WAS SET INCORRECTLY OR LEFT ON DEFAULT, RESULTING IN A UF RATE OF 1,090 ML/HR. THE REPORTED PROBLEM MAY BE ATTRIBUTED TO USER ERROR IN FAILURE TO SET THE MACHINE PROPERLY. THE STAFF ALSO FAILED TO IDENTIFY THE INCONSISTENCY BETWEEN THE UF RATE AND THE DESIRED UF GOAL (TOTAL FLUID TO BE REMOVED). THE MACHINE HAS BEEN BACK IN USE WITH NO REPORTED PROBLEM. THIS MAKES IT VERY UNLIKELY THAT THERE WAS A FAILURE OF THE MACHINE ULTRAFILTRATION CONTROL. (B)(4).

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REQUESTED FOR A DEVICE INVESTIGATION AFTER A PT BECAME UNCONSCIOUS BUT BREATHING DURING A HEMODIALYSIS TREATMENT. THERE WAS NO REPORTED DEVICE PROBLEM. THE PT HAD A PRE DIALYSIS WEIGHT OF (B)(6). HIS DRY WEIGHT IS (B)(6). THE ULTRAFILTRATION (UF) GOAL WAS REPORTEDLY SET AT 500 ML. UF RATE WAS RECORDED AS 1,090 ML/HR THROUGHOUT THE TREATMENT. THE PT WAS GIVEN 1,500 ML OF SALINE AND WAS DISCHARGED ALERT WITH A STABLE BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other