BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080466 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05610
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 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). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER'S MOM REPORTED HAVING TROUBLE WITH CASSETTES. THEY ARE NOT PRIMING AND PATIENT DID NOT DO DIALYSIS LAST NIGHT. ONE LINE WAS TOO CLOSE AND THE OTHERS HAVE PIN HOLES BECAUSE IT SQUIRTED OUT. DURING FOLLOW UP, THE HP'S MOTHER STATED THAT THE CASSETTE LOOKED LIKE IT WAS MELTED RIGHT WHERE THE LINES COME OUT OF THE HOMECHOICE AND THE LINES FUSED TOGETHER. TWO OF THE LINES FROM THAT STARTED LEAKING DUE TO THE PRESSURE AND HAD LITTLE PIN HOLES IN IT.

    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 H11A23015

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR HOMECHOICE