BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 3145164 · Received May 30, 2013

    Report

    Report Number
    8030665-2013-00340
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE COMPLAINT IS UNCONFIRMED. THE DRAIN BAG WAS CUT, DUE TO THE NATURE OF THE CUTS, THESE WERE MADE DURING EMPTYING PROCESS OF THE BAG. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPEC.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING CYCLER, AFTER TREATMENT WAS COMPLETED. PT HAD NO ADVERSE EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237719 NEWTON IQ W/STAY SAFE CYCLER SET KDI REYNOSA MANUFACTURING NEWTON IQ W/ STAY SA 12PR08113

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWTON CYCLER