BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1832615 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03385
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WHILE PRIMING WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. PRODUCT SURVEILLANCE CONTACT ED THE CAREGIVER AFTER THIS REPORTED EVENT WHO STATED THE HOME PATIENT (HP) WAS DOING FINE AND HAS CONTINUED THERAPY. PRODUCT SURVEILLANCE ALSO SPOKE WITH THE HP'S NURSE WHO STATED THE HP WAS DOING FINE AND IS CONTINUING THERAPY. THE NURSE ADDED THEY ARE ALREADY MONITORING THE HP FOR ANY CHANGES IN CONDITION, AS HP WAS FAIRLY NEW ON THE HC MACHINE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LEAK (OVERPRIME SITUATION) ON THE HOMECHOICE (HC) WHILE PRIMING. HOME PATIENT (HP) REPORTED, SHE WAS TRYING TO RE-PRIME LINE AND FLUID STARTED GOING EVERYWHERE. HP HAD NEVER CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED HP WITH ENDING CURRENT THERAPY ON THE HC SO THAT SHE COULD START OVER WITH NEW SUPPLIES. ON (B)(4) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE NURSE WHO REPORTED HP IS NEW TO THE CYCLER AND WAS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR