BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2791775 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02448
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE REPORTED PROBLEM OF IIPV WAS NOT CONFIRMED THROUGH SAMPLE EVALUATION OR EVENT HISTORY LOG REVIEW. OFF CYCLER DRAIN VOLUMES ARE NOT RECORDED BY THE CYCLER AND CANNOT BE CONFIRMED. THE CAUSE WAS UNDETERMINED. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING FOLLOW UP REGARDING A LOW ULTRAFILTRATION (UF) ALARM ON (B)(6) 2012, PRODUCT SURVEILLANCE RECEIVED A REPORT FROM THE REGISTERED NURSE (RN) THAT THE PATIENT HAD DRAINED 3900ML LAST WEEK. THE NURSE STATED THAT THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2200ML. THEREFORE, THIS EVENT MEETS INCREASE INTRA-PERITONEAL VOLUME (IIPV) CRITERIA (ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). THE NURSE STATED THAT THE PATIENT DOES A MIDDAY EXCHANGE OF 2000ML. SHE STATED THAT THE PATIENT DOES NOT DRAIN WELL WHILE LAYING DOWN, SO SHE USUALLY HAS TO FINISH DRAINING BY SITTING OR STANDING. SHE STATED THAT THE PATIENT DOES NOT HAVE ANY ALARMS SUCH AS A LOW DRAIN VOLUME ALARM. SHE STATED THAT THE PATIENT'S UF VOLUME HAS BEEN VERY LOW; ONLY ABOUT 200ML FOR THE WHOLE NIGHT. SHE STATED THAT LAST WEEK THE PATIENT WAS NOT DRAINING AND THEY PERFORMED A MANUAL EXCHANGE AND DRAINED 3900ML. SHE STATED THAT THE PATIENT REPORTED FEELING FULL WHEN THEY DRAINED OUT 3900ML. THE NURSE STATED THAT THE PATIENT JUST STARTED ON PERITONEAL DIALYSIS (PD), SO SHE BELIEVED IT WOULD BE BENEFICIAL EXCHANGE THE HOMECHOICE FOR A NEW MACHINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE