BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 3755452 · Received February 11, 2014

    Report

    Report Number
    8030665-2014-00158
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 18, 2014
    Report Date
    January 18, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    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) PATIENT REPORTED DURING TREATMENT THE SYSTEM ALARMED FO A SCALE FAULT. WHILE ATTEMPTING TO CLEAR THE FAULT THE PATIENT DISCOVERED FLUID LEAKING FROM THE UNUSED LINES ON THE SYSTEM. THE PATIENT HAD BEEN INSTRUCTED TO CLAMP THE UNUSED LINES, AND TIE THEM INTO A KNOW TO GET THEM OUT OF THE WAY. THE PATIENT FORGOT TO CLAMP THE LINES; SHE ONLY HAD THEM IN A KNOT. THE PATIENT WAS ADVISED TO DISCONNECT AND SETUP WITH A NEW SET. THE CYCLER SET WAS DISCARDED. LATER FOLLOW UP DETERMINED THAT THE PATIENT'S EFFLUENT WAS CLEAR. THERE WERE NO SIGNS OF INFECTION AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89596 NEWTON IQ W/STAY SAFE CYCLER SET KDJ REYNOSA MANUFACTURING 13KR08029

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWTON CYCLER