BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2182938 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09917
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED. BASED ON AVAILABLE INFORMATION WITHIN THE COMPLAINT FILE, THE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR- BYPASSED LOW DRAIN VOLUME ALARM IN THE INITIAL DRAIN AND KEPT HITTING STOP/GO TO GET PAST IT. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR THE LOW DRAIN VOLUME ALARM, THE HOME PATIENT (HP) REPORTED THE USE ERROR OF ATTEMPTING TO BYPASS THE INITIAL DRAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1