BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1992058 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01992
    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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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).

    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 3 OF 4. A SUPPLY BAG HAD BECOME DISCONNECTED DURING THERAPY. GTS EXPLAINED THE ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE CAREGIVER CYCLE POWER. GTS THEN ADVISED THE CAREGIVER THAT THERAPY HAD ENDED AND THEY WOULD NEED TO START OVER WITH NEW SUPPLIES OR FINISH THE PATIENT'S THERAPY MANUALLY. THE CAREGIVER ELECTED TO PERFORM A MANUAL EXCHANGE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED SHE WAS SLEEPING WHEN THE ERROR OCCURRED AND DID NOT DISCONNECT ANYTHING. THE PATIENT VERIFIED THE SUPPLIES WERE DISCARDED AND WAS UNABLE TO PROVIDE THE LOT INFORMATION. THE PATIENT EXPLAINED SHE WAS ABLE TO RESUME THERAPY THE FOLLOWING NIGHT WITHOUT ANY PROBLEMS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE APD CYCLER 5C4471R (REFURBISHED)