BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3062484 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09477
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS CONDITION IS AN ANCILLARY SERVICE EVENT. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED IN THERAPY DURING NIGHT DRAIN CYCLE FOUR. THE PATIENT'S ULTRAFILTRATION READING WAS 1104ML, WHICH INDICATES THAT THE HOME PATIENT (HP) DRAINED 1104ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166177 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1