BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2103497 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06534
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 12, 2011
    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). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED. THE RESULTS OF A BATCH REVIEW REVEALED NO PROBLEMS DURING THE MANUFACTURING PROCESS AND NO DEVIATIONS FROM STANDARD PROCEDURE. A ROOT CAUSE WAS NOT IDENTIFIED. 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 A FOLLOW UP PHONE CALL FOR A REPORT OF AIR IN THE LINE, SEE REPORT 1423500-2011-06111, THE HOME PATIENT MENTIONED LEFT SHOULDER PAIN WHICH OCCURRED ON (B)(6) 2011 THAT WAS THOUGHT TO HAVE BEEN CAUSED BY AIR IN THE LINE. NOTHING WAS NOTICED WITH THE SUPPLIES ON THAT DAY. A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11B01027 AND THE PATIENT HAS BEEN PERFORMING THERAPY FINE SINCE THE EVENT WITH NO REPORTED PAIN. THE NURSE WAS ALSO CONTACTED REGARDING THIS EVENT AND THE PATIENT WAS INVOLVED, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11B01027

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOME CHOICE