BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1961876 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00669
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) OCCURRING DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NO ROOT-CAUSE HAS BEEN DETERMINED. USER ERROR WAS SUSPECTED, BUT THE LABELING REVIEW FOUND THE LABELLING WAS ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM WHILE USING THE HOMECHOICE (HC) DURING THERAPY. (B)(4) REVIEWED THE PROGRAMMING WITH THE PATIENT. THE PATIENT STATED THEY BYPASSED THE INITIAL DRAIN AND RESOLVES THE ALARM BY PRESSING "STOP" THEN "GO". (B)(4) EXPLAINED POSSIBLE CAUSES FOR THE ALARM AND THE PATIENT EXPLAINED THEY DRAIN INTO A CONTAINER WITH NO AIR GAP AT THE END OF THE LINE. THE PATIENT WAS ADVISED TO CONTACT THEIR DIALYSIS NURSE AND CONTACT BAXTER WHEN GETTING ALARMS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)