BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXELTRA PLUS 210 - SINGLE USEHIGH FLUX DIALYZER

    MDR report key: 1920342 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06765
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    PMA / PMN Number
    K030975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF BEING UNABLE TO CLEAR AIR FROM THE DIALYZER COULD NOT BE CONFIRMED NOR REFUTED AS THE IMPLICATED SAMPLE WAS NOT PROVIDED TO THE SUPPLIER FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED, SO NO BATCH REVIEW WAS PERFORMED BY THE MANUFACTURING FACILITY. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER REPORTED TO A BAXTER SALES REP THAT THIS ISSUE WAS RELATED TO TRAINING AND NOT RELATED TO A QUALITY DEFECT IN THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS A RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED A COMPLAINT REGARDING ONE EXELTRA PLUS 210 - SINGLE USEHIGH FLUX DIALYZER. THE CUSTOMER STATED THAT THE PATIENTS ARE COMPLAINING THAT THEY CANNOT CLEAR THE AIR FROM DIALYZER. NOTE: THE NURSE REQUESTS TRANSDUCERS TO BE PUSHED INTO THE MACHINE PROPERLY IN ORDER TO AVOID THE AIR ENTRY. THE NURSE ALSO REQUESTS FROM THE PATIENTS TO ENSURE THAT THE RED AND BLUE DIALYSATE HOSES ARE PUSHED INTO THE SIDE OF THE DIALYZER UNTIL A CLICK IS HEARD. FINALLY THE NURSE REQUESTS THE VENOUS AND ARTERIAL LINES TO BE SCREWED IN PROPERLY TO AVOID AIR ENTRY. THE PATIENTS ARE ALSO INSTRUCTED TO ENCIRCLE AWHILE DURING PRIMING WITH ARTERIAL ON THE BOTTOM AND VENOUS ON THE TOP. A FOLLOW UP WAS DONE VIA PHONE CALL; THE CUSTOMER STATED THAT THERE ARE ONLY A FEW PATIENTS THAT ARE HAVING ISSUES WITH THE AIR IN THE DIALYZER. THE CUSTOMER STATED THAT SHE SPOKE TO SALES REP AND HE HAS OFFERED ASSISTANCE AND TIPS TO AVOID AIR IN THE DIALYZER. THE CUSTOMER STATED THAT THEY ARE STILL TRYING TO DETERMINE IF THERE THIS IS A TRAINING ISSUE OR A TECHNICAL ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELTRA PLUS 210 - SINGLE USEHIGH FLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD*

    Patients

    Seq Age Sex Outcome Treatment
    1