BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3180336 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-15999
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DESIGN HISTORY FILE WAS PERFORMED WITH NO ABNORMALITY NOTED. A REVIEW OF THE SERVICE HISTORY WAS PERFORMED WHICH INDICATED THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF AN IIPV-ADULT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO DEVICE ANALYSIS COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED AN IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENT WHILE PERFORMING PERITONEAL DIALYSIS (PD) ON THE HOMECHOICE (HC) CYCLER. A HIGH DRAIN 104 ALARM OCCURRED ON THE HC DURING CYCLE 4. A HIGH DRAIN 104 ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THE ULTRA FILTRATION (UF) WAS 2101ML. THE FILL VOLUME (FV) WAS 2700ML. THE TOTAL UF WAS 2803ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HP STATED THAT A UF OF 2101ML WAS NORMAL FOR THEM. THE HP DOES A MANUAL EXCHANGE DURING THE DAY DRAINING OUT THEIR LAST FILL. THE HP GETS ON THE HC EMPTY. THE HP WOULD CALL THEIR REGISTERED NURSE (RN) REGARDING THE ALARM. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281303 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE