BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2911382 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00918
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF IIPV WAS CONFIRMED OVER THE PHONE. THE ROOT CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH FEELING PAIN IN HER STOMACH AND TOO FULL DURING DWELL 1 OF 4 ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE NURSE TO DO A MANUAL DRAIN OF 4367ML. THE NURSE STATED THE HOME PATIENT(HP) DID A MANUAL BAG AT HOME OF 2000ML. THE NURSE STATED THE HP WENT TO THE HOSPITAL AND THEY PUT HER ON THE HC AND THE INITIAL DRAIN IS SET TO 10ML. THE INITIAL DRAIN VOLUME WAS 68ML. THE THERAPY IS CONTINUOUS CYCLE PERITONEAL DIALYSIS WITH A TOTAL VOLUME OF 12000ML, TOTAL TIME OF 10:00, FILL VOLUME OF 2200ML, LAST FILL VOLUME OF 0ML, 4 CYCLES, AND INITIAL DRAIN ALARM 10ML. THE TSR ASSISTED THE NURSE TO END THERAPY AND ADVISED TO CONTACT THE PERITONEAL DIALYSIS NURSE. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17361 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1