BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3181850 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16124
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DRAIN OF 20 LITERS WAS THE TOTAL DRAIN AMOUNT FOR THE THERAPY PERFORMED ON (B)(6) 2013, NOT THE INITIAL DRAIN AMOUNT. THEREFORE, THIS DOES NOT MEET THE CRITERIA FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV). A REVIEW OF THE DEVICE AND SERVICE HISTORY RECORDS SHOWED NO ABNORMALITIES THAT COULD HAVE CAUSE OR CONTRIBUTED TO THE REPORTED EVENT. 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) HAD DRAINED OFF 20 LITERS IN THEIR FIRST DIALYSIS SESSION ON A HOMECHOICE (HC) MACHINE. THIS DRAIN MEETS THE CRITERIA FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE REGISTERED NURSE (RN) WAS CALLING BECAUSE THEY WERE EXPECTING TO GET A HIGH DRAIN ALARM SINCE THEY ARE TRYING TO GET HIGH DRAINS OFF OF THE HP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED WHEN THE HIGH DRAIN ALARM WOULD OCCUR. THE TSR WAS NOT ABLE TO GET FURTHER INFORMATION. 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
    282282 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1