BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073081 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05215
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 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 AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE CAUSE IS AN OPEN CLAMP ON THE PATIENT LINE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. 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 CHECK PATIENT LINE ALARM WHILE USING THE HOMECHOICE (HC) DURING THE "CONNECT YOURSELF" PROMPT. THE PATIENT STATED THE BUBBLES WERE SMALLER THAN INCH. (B)(4) HAD THE PATIENT PRESS "GO' TO START THERAPY. ALL BUBBLES WENT BACK INTO THE HC. THE DRAIN VOLUME INCREASED NORMALLY. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO STATED THEY WENT AHEAD AND COMPLETED THEIR THERAPY AND THAT THEIR THERAPY HAD BEEN GOING WELL SINCE THE REPORTED EVENT. THE PATIENT THOUGHT THE AIR IN THE LINE WAS DUE TO USE ERROR AS THEY FORGOT TO OPEN THEIR LINE CLAMP DURING SETUP. THE PATIENT DID NOT SEE ANYTHING UNUSUAL ABOUT THEIR SUPPLIES OR ANY LEAKS IN THE SUPPLIES. THE PATIENT DISCARDED THE SETUP AND DID NOT KNOW THE LOT INFORMATION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE PRO