BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 1526837 · Received November 12, 2009

    Report

    Report Number
    8030665-2009-00061
    Event Type
    Injury
    Date Received
    November 12, 2009
    Date of Event
    October 2, 2009
    Report Date
    November 12, 2009
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K811986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT OF AN EVENT HAS BEEN RECEIVED FROM A PERITONEAL DIALYSIS NURSE AND REPORTED THE FOLLOWING: RN REPORTED THAT THE CYCLER TUBING LEAKED FROM THE SITE WHERE IT BREAKS OFF TO ALLOW THE PT TO PAUSE AND 2-3 DAYS FOLLOWING THE EVENT, THE PT WAS DIAGNOSED WITH PERITONITIS. THE NURSE HAS BEEN CONTACTED FOR ADD'L INFO. IT HAS BEEN LEARNED THAT THE TUBING SET LEAKED AT THE SECOND CONNECTOR WHILE IT WAS STILL UNOPENED AND WRAPPED IN THE SHRINK WRAP. THE PT THEN REPORTED SYMPTOMS OF ABDOMEN PAIN AND CLOUDY FLUID. THE PT WAS THEN HOSPITALIZED AND TREATED WITH INTRAPERITONEAL ANTIBIOTICS. AT THIS TIME, HE HAS BEEN DISCHARGED TO HIS HOME AND IS DOING FINE AND ABLE TO CONTINUE PERITONEAL DIALYSIS AS ORDERED. THE SAMPLE IS AVAILABLE, HOWEVER, THE LOT IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O| R