BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2103246 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06517
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 9, 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 LEAK 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CARE GIVER (CG) SENT AN EMAIL TO REPORT THAT WHEN A CASSETTE WAS HOOKED UP TO THE BAG IT LEAKED. A FOLLOW UP WAS DONE VIA PHONE. THE CG REPORTED THAT HE CONNECTED THE SOLUTION BAG TO THE CASSETTE AND NOTICED A LEAK. THERE WAS PATIENT INVOLVEMENT, 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 H11C10091

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOME CHOICE