BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 833791 · Received March 30, 2007

    Report

    Report Number
    8030665-2007-00020
    Event Type
    Injury
    Date Received
    March 30, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 30, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED ELECTRONIC REPORT FROM A PERITONEAL DIALYSIS PT WHO REPORTED THEY MANUALLY HAD TO PRIME THESE LINES FOR TREATMENT. THE PT WAS CONTACTED AND THE PTS' WIFE REPORTEDLY USED A DRY LINE THAT WAS NOT PRIMED FOR THE PERITONEAL DIALYSIS THERAPY. THE THERAPY WAS COMPLETED AS PRESCRIBED WITH THE USE OF THESE LINES. IT WAS LEARNED IN 2007, THAT THE PTS' WIFE NOTICED THAT THE EFFLUENT BECAME CLOUDY WITH SOME SEDIMENT THAT WAS SEEN. ALSO, HER HUSBAND HAD DEVELOPED A FEVER AND HAD SOME NAUSEA. THE PT WAS SEEN AND EVALUATED IN THE CLINIC THREE DAYS BEFORE, AND WAS DIAGNOSED WITH PERITONITIS. THE PT REC'D ANTIBIOTIOTIC THERAPY. A COMPANION SET IS AVAILABLE FOR EVAL. IT WAS ALSO LEARNED THAT THIS PT HAD NOT FULLY RECOVERED FROM PERITONITIS AND WILL CONTINUE WITH ANTIBIOTIC THERAPY AT THIS TIME. ALSO, THIS PT IS ABLE TO CONTINUE PERITONEAL DIALYSIS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TUBING SET FJK REYNOSA MANUFACTURING NA 6NR259

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R