BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 955159 · Received November 28, 2007

    Report

    Report Number
    8030665-2007-00095
    Event Type
    Injury
    Date Received
    November 28, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 28, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: NO INDICATION OF THE REPORTED DEFECT FOUND DURING DHR REVIEW. LOT MET ALL RELEASE CRITERIA. SAMPLE ANALYSIS: THE SAMPLE WAS NOT AVAILABLE FOR AN EVALUATION. THE COMPLAINT IS NOT CONFIRMED. FMC WILL CONTINUE TO MONITOR TRENDS AND DEFECTS PER CURRENT PROCEDURE. SINCE THIS COMPLAINT WAS NOT CONFIRMED, NO CORRECTIVE ACTION HAS BEEN DOCUMENTED AT THIS TIME RELATING TO THIS COMPLAINT.

    Description of Event or Problem · 1

    RECEIVED AN ELECTRONIC REPORT FROM A PERITONEAL DIALYSIS RN WHO INDICATED THAT A HOME PATIENT HAS BEEN DIAGNOSED WITH PERITONITIS. THE PATIENT HAD DISCOVERED A LEAK IN HER CYCLER TUBING SET PATIENT LINE. SHE NOTICED HER SHEETS WERE WET AND REALIZED THAT THE TUBING WAS LEAKING NEXT TO THE SECOND CONNECTOR. SHE THEN CONTACTED TECHNICAL SERVICES. THE PATIENT THEN CHANGED THE TUBING SET AND APPLIED NEW FILL BAGS AND THEN RESUMED HER TREATMENT. AS A RESULT OF THIS EVENT, THIS PATIENT HAS BEEN DIAGNOSED WITH PERITONITIS. IT WAS ALSO REPORTED THAT THE PATIENT DISCARDED THIS CYCLER TUBING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TREATMENT SET KDJ REYNOSA MANUFACTURING NA 7KR200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other| R