BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 3202172 · Received June 28, 2013

    Report

    Report Number
    8030665-2013-00397
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDJ
    PMA / PMN Number
    K904706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE BLUE PUMP TUBING CONNECTED TO A SECTION OF DRAIN LINE WAS RETURNED TO THE MFR FOR PHYSICAL EVALUATION. A FUNCTIONAL TEST WAS PERFORMED AND NO LEAKS WERE DETECTED. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCE DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE PT ALLEGED A LEAK OCCURRED AT THE CONNECTION OF THE DRAIN LINE AND BLUE PUMP TUBING. THERE WAS NO FLUID IN, ON OR NEAR THE CYCLER. LEAK WAS FOUND AFTER TREATMENT WAS COMPLETED. THE PT'S PD RN STATED WHO STATED THE PT NEEDED NO MEDICAL INTERVENTION. EFFLUENT REMAINS CLEAR. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296614 NEWTON IQ W/STAY SAFE CYCLER SET KDJ FRESENIUS MEDICAL CARE NORTH AMERICA 13AR08875

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NEWTON CYCLER