BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3133153 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13478
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY REVEALED NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE HAD BEEN PREVIOUSLY SERVICED ON (B)(4) 2013 FOR AN UNRELATED ISSUE. IT WAS TESTED AND WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATIONS. THE DEVICE PASSED FINAL TESTING AND CALIBRATION AFTER SERVICING. A REVIEW OF THE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSE OR CONTRIBUTED TO THE REPORTED INCREASED INTRA-PERITONEAL VOLUME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) WAS FEELING OVERFILLED ON A HOMECHOICE (HC) MACHINE DURING DWELL FOUR OF FOUR. THE HP HAD A FILL VOLUME OF 2500 ML AND HAD A DRAIN OF 4200 ML. THIS DRAIN MET INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP IN RETRIEVING THERAPY DATA AND EXPLAINED THE DATA TO THE HP. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234595 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL SOLUTION