BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4304622 · Received December 8, 2014

    Report

    Report Number
    1416980-2014-44452
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 2, 2014
    Report Date
    November 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED "DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1599ML, INDICATING THE HOME PATIENT (HP) DRAINED 1599ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2400ML." HOWEVER, UPON FURTHER INVESTIGATION OF THIS EVENT, IT WAS VERIFIED IN THE EVENT HISTORY LOG THAT THE INITIALLY REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT DID NOT OCCUR. THE ACTUAL DRAIN VOLUME FOR DRAIN 5 OF 5 WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 22:30:59 WAS 3618ML. THIS VOLUME DOES NOT MEET THE REQUIREMENT TO BE CONSIDERED AN IIPV EVENT AND IT IS BELOW 160% OF THE TOTAL PRESCRIBED FILL VOLUME. THIS IS NO LONGER A REPORTABLE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 22:30:59. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 1599ML, INDICATING THE HOME PATIENT DRAINED 1599ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2400ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791808 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR