BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 5388755 · Received January 25, 2016

    Report

    Report Number
    1416980-2016-01782
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    January 10, 2016
    Report Date
    February 3, 2016
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THIS EVENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A HIGH DRAIN 101 (NIGHT DRAIN #1) ALARM. THIS ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME. THERE WERE NO BYPASSES OR MANUAL DRAINS, AND THERE WERE NO THERAPY CHANGES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THAT THE INITIAL DRAIN ALARM (IDA) IS SET TO 0ML AND THE PATIENT INDICATED THAT THEY DO A MANUAL BAG IN THE DAY TIME OF 2000ML EXTRANEAL. THE TSR EXPLAINED THAT SINCE THE IDA IS SET TO 0ML, AS SOON AS IT DETECTS THAT THE PATIENT IS EMPTY, IT WOULD ADVANCE TO FILL. THE TSR EXPLAINED TO THE PATIENT THE IMPORTANCE OF SETTING THE IDA AND THAT IT TAKES INTO CONSIDERATION THE MANUAL BAG OF 2000ML TO AVOID THIS SCENARIO. THE TSR EXPLAINED WHY THEY NORMALLY SWAP THE HOMECHOICE OUT IN THIS INSTANCE, BUT SINCE THE IDA WAS NOT SET, THAT WAS WHY THE SITUATION OCCURRED. THE TSR REFERRED THE PATIENT TO THE PERITONEAL DIALYSIS REGISTERED NURSE TO SET THE IDA TO AVOID THIS SCENARIO IN THE FUTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46570 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR