BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1992130 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01994
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 1 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT'S CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE PATIENT'S THERAPY, IN DWELL CYCLE 1. THE CAREGIVER STATED, SHE HAD CYCLED POWER AND CALLED THE PATIENT'S DIALYSIS NURSE WHO INSTRUCTED HER TO CALL BAXTER. GTS EXPLAINED THE ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND THAT THE PATIENT WOULD NEED TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER WHO VERIFIED THE SUPPLIES WERE DISCARDED AND WAS UNABLE TO PROVIDE THE LOT INFORMATION. THE CAREGIVER STATED, THE PATIENT STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY WITHOUT ANY PROBLEMS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 86 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)