BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2202618 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10586
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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 COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED. THE SAMPLE WAS EVALUATED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW WAS NOT COMPLETED BECAUSE NO USE ERROR WAS SUSPECTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) FOR ASSISTANCE AFTER A LINE SEPARATED FROM A BAG DURING FILL ON THE HOME CHOICE (HC). GTS ASSISTED THE CARE GIVER (CG) TO END THE THERAPY AND ADVISED THE CG TO CONTACT THE NURSE. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE CG, WHO SAID THEY NOTIFIED THE NURSE. THE CG SAID THEY DID A MANUAL EXCHANGE AND THERAPY WENT WITHOUT COMPLICATIONS THE NEXT NIGHT. THE CG SAID THE NURSE ADVISED THEM TO LOOK FOR ANY ADVERSE REACTIONS HOWEVER THE HP HAD NOT EXPERIENCED ANY. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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 H11C31097

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR HOMECHOICE| DIANEAL