BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2192518 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10311
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PARTICULATE MATTER WAS CONFIRMED IN THE LAB. THE RESULTS OF A SAMPLE EVALUATION REVEALED A PARTICLE BETWEEN TUBING AND CONNECTOR BY THE RING SEAL. THE ROOT CAUSE WAS NOT IDENTIFIED. THE CAUSE WAS UNDETERMINED. A LABEL REVIEW WAS NOT PERFORMED DUE TO UNSUSPECTED USER ERROR. 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.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REGISTERED NURSE (RN) CALLED ON (B)(6) 2011 TO REPORT THAT THE CAREGIVER (CG) BROUGHT IN PATIENT LINE LUER CONNECTION CUT FROM CASSETTE. THE LOT NUMBER WAS UNKNOWN AT THIS TIME. THE CG HAD FOUND A BLACK SPOT FOUND IN THE CONNECTION WHERE THE LUER ATTACHES TO PATIENT LINE. THE SAMPLE WAS UNUSED. THE RN SAID THAT THE CG WILL TRY TO LOCATE LOT NUMBER. THERE WAS PATIENT INVOLVEMENT. IT WOULD DURING SET UP. THERAPY HAS BEEN GOING WELL SINCE INCIDENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO HOMECHOICE