BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/ STAY SAFE CYCLER SET

    MDR report key: 3099296 · Received May 2, 2013

    Report

    Report Number
    8030665-2013-00254
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    RN REPORTED THAT A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE TUBING SET FROM THE MANIFOLD DURING TREATMENT. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PATIENT HAD NO ADVERSE EFFECTS. SAMPLE WAS DISCARDED BY THE PATIENT; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193337 NEWTON IQ W/ STAY SAFE CYCLER SET KDJ REYNOSA MANUFACTURING 12PR08109

    Patients

    Seq Age Sex Outcome Treatment
    1