BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2594758 · Received May 31, 2012

    Report

    Report Number
    1423500-2012-11564
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    April 30, 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). ADDITIONAL INFORMATION: 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 1637 ML DURING THERAPY INITIATED ON (B)(4) 2012 20:30, 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)(4) 2012 20:30. A PARTIAL FILL WAS DELIVERED DURING FILL 6 OF 6 OF 1370 ML, WHICH WAS LESS THAN THE EXPECTED TIDAL VOLUME OF 1520 ML. REVIEW OF THE EVENT LOG REVEALED THE CYCLE 6 DRAIN WAS COMPLETED ON (B)(4) 2012 AT 4:49 AND THE USER'S ACTUAL DRAIN VOLUME DURING CYCLE 6 WAS 3005 ML. THE ACTUAL DRAIN VOLUME OF 3005 ML IS 158% OF LARGEST PRESCRIBED FILL VOLUME (LPFV) OF 1900 ML; THEREFORE, THIS INCIDENT DOES NOT MEET IIPV CRITERIA. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    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.

    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 20:30:15. DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 1637ML, INDICATING THE HOME PATIENT (HP) DRAINED 1257ML 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