BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 3190470 · Received June 21, 2013

    Report

    Report Number
    8030665-2013-00389
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST 1 MONTH. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED FLUID LEAKED FROM THE TUBING SET. PATIENT WAS UNSURE WHERE THE LEAK OCCURRED. THE PATIENT COULD NOT IDENTIFY THE ORIGIN OF THE LEAK AND HAD NO ADVERSE EFFECTS FROM THE TREATMENT. PATIENT WAS NOT PRESCRIBED ANTIBIOTICS AND EFFLUENT IS STILL CLEAR. SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283932 NEWTON IQ W/STAY SAFE CYCLER SET KDJ FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1