BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4032979 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27881
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS IS AN ANCILLARY SERVICE EVENT. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED. THE HOMECHOICE DEVICE RECEIVED FUNCTIONAL AND ELECTRICAL TESTING. THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS DUE TO AN UNRELATED ISSUE. THERE WERE NO ADDITIONAL DEFECTS OR MALFUNCTIONS FOUND. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 18:01:23. DURING NIGHT DRAIN CYCLE 13, THE PATIENT'S ULTRAFILTRATION READING WAS 100ML, INDICATING THE HOME PATIENT (HP) DRAINED 100ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 160ML. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514140 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1