BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2594760 · Received May 31, 2012

    Report

    Report Number
    1423500-2012-11565
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Removal / Correction Number
    1423500-01/08/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. REVIEW OF THE DEVICE'S THERAPY LOG REVEALED THE USER HAD AN ULTRAFILTRATION (UF) VOLUME OF 1239 ML DURING THERAPY INITIATED ON (B)(6) 2012 20:28, WHICH WAS SUSPECTED TO BE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) OF FLUID. AN IIPV IS ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, AS DEFINED IN THE (B)(4) CLINICAL HAZARDS LIST. A REVIEW OF THE DEVICE'S EVENT LOG WAS PERFORMED FOR THE THERAPY INITIATED ON (B)(6) 2012 20:28. WITH THE FV= 1900ML AND A 80% TIDAL THERAPY, THE ACTUAL DRAIN VOLUME WOULD NEED TO EXCEED 3040 ML AND THE UF TO EXCEED 1520 ML (1520 ML + TIDAL FV 1520ML = 3040 ML MAX DRAIN VOLUME). THE ACTUAL DRAIN VOLUME IS NOT AVAILABLE BUT WITH A UF OF 1239 THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 20:28:03. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1239ML, INDICATING THE HOME PATIENT (HP) DRAINED 1239ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1900ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1