BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY CYCLER SET

    MDR report key: 4174544 · Received August 11, 2014

    Report

    Report Number
    8030665-2014-00618
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE, REYNOSA MFG
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED THAT HER CYCLER ALARMED FOR A MID-FILL PROBLEM DURING FILL 1. SHE WAS ADVISED TO RESET WITH NEW SUPPLIES. WHEN SHE WAS SETTING UP SHE FOUND A FLUID LEAK FROM THE SET DUE TO A TUBE BEING CUT BY A CRACK IN THE HOLDING TRAY. THE PT HAD ANOTHER TRAY AND SETUP WITH A NEW SET TO COMPLETE TREATMENT. THE SET WAS DISCARDED. DURING FOLLOW UP THE PT'S PD NURSE REPORTED THAT SHE HAS NOT HAD ANY SIGNS OF INFECTION. SHE WAS NOT TREATED WITH ANY ANTIBIOTIC. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476261 NEWTON IQ W/STAY CYCLER SET KDJ FRESENIUS MEDICAL CARE, REYNOSA MFG 14BR08034

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NEWTON CYCLER