BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3151912 · Received June 7, 2013

    Report

    Report Number
    1416980-2013-14597
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    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). THE ACTUAL DATE OF THE ALARM IS UNKNOWN. IT WAS REPORTED THAT IT OCCURRED OVER THE WEEKEND, (B)(6) 2013. 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): AS THE HOMECHOICE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) RECEIVED A HIGH DRAIN 104 ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN FOUR OF FOUR. A HIGH DRAIN ERROR ALARM IS INDICATIVE OF AN IIPV EVENT. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE REGISTERED NURSE (RN) STATED THAT THE ALARM OCCURRED OVER THE WEEKEND AND THAT HE WAS UNSURE WHICH PATIENT WAS INVOLVED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ITS TRIGGERS. THE RN STATED THAT ALL OF HIS RENAL PATIENTS WERE FINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252419 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1