BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2911686 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00934
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A HIGH DRAIN VOLUME ALARM BY DEFINITION MEETS IIPV CRITERIA. REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF HIGH DRAIN (IIPV-ADULT). THE CAUSE WAS A PHYSIOLOGICAL CONDITION RELATED TO THE CATHETER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN ALARM AT THE END OF THERAPY ON THE HOMECHOICE MACHINE (HC). THE CAREGIVER (CG) STATED THE HOME PATIENT'S (HP) CATHETER WAS NOT WORKING PROPERLY. THE CG STATED THIS OCCURRED SEVERAL DAYS AGO AND HAS SINCE BEEN ADJUSTED. 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
    18609 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

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