BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2990016 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05268
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    July 26, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE IIPV WAS CONFIRMED BY REVIEW OF THE LOGS. THE ASSIGNABLE CAUSE OF THE IIPV WAS UNDETERMINED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED AS A HIGH DRAIN 101 ALARM WHICH OCCURRED IN THE ALARM LOG ONLY ON (B)(6) 2012, AT 12:58:17. THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2200 ML. DRAIN VOLUME WAS NOT AVAILABLE DUE TO THERAPIES BEING PERFORMED AFTER THE DATE OF (B)(6) 2012 AND OVERWRITING THE PREVIOUS INFORMATION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93033 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR