BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS PD +IQ CARD CYCLER (NEWTON IQ)

    MDR report key: 4044173 · Received August 15, 2014

    Report

    Report Number
    2937457-2014-02138
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K002892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. A VISUAL INSPECTION WAS PERFORMED. THERE WERE NO DISCERNIBLE PHYSICAL DAMAGE TO THE NEWTON CYCLER. A STIMULATED TREATMENT WAS CONCLUDED WITH NO ALARMS OR ISSUES. THE REPORTED SYMPTOMS WERE NOT CONFIRMED. ALL FUNCTIONAL TESTS PASSED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE WERE NO UNEXPECTED VARIANCES, ADJUSTMENTS OR COMMENTS NOTED IN THE DEVICE RECORDS. A SEARCH OF THE COMPLAINT TRACKING SYSTEM LISTED NO OTHER COMPLAINTS FOR THIS DEVICE WITH THE REPORTED SYMPTOMS. A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPT. PER THE PHARMACOVIGILANCE ASSOCIATE MED DIR, IT IS UNLIKELY THAT THE CYCLER FILLED THE PATIENT WITH 7000 ML OF SOLUTION. THE TOTAL TREATMENT VOLUME OF 12000 ML AND TOTAL SOLUTION VOLUME IN BAGS: 15000 ML. IT IS HIGHLY UNLIKELY THAT THE CYCLER INFUSED THE PATIENT WITH THE LARGE VOLUME AND STILL HAD ENOUGH SOLUTION TO COMPLETE TREATMENT. THERE WAS NO REPORTED INJURY. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MED CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN 21 MARCH 2011 AND 11 MARCH 2013.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED FRESENIUS TECHNICAL SUPPORT REGARDING ALARMS IN DRAIN 6, EMPTYING ALARM AND WEIGHT BAG EMPTY. THE PATIENT STATED THAT THE CYCLER HAS BEEN ALARMING ALL NIGHT. TECHNICAL SUPPORT REVIEWED THE DATA SHEET: FILL VOLUMES WERE 2000 ML. DRAIN 1 = 1760 ML, DRAIN 2 = 1760 ML, DRAIN 3 = 7160 ML, DRAIN 4 = 2250 ML, DRAIN 5 = 1910 ML, AND DRAIN 6 = 2310 ML. THE PATIENT REPORTED FEELING FULL, BUT NOT 7 L FULL. THE PATIENT COMPLETED THE FULL TREATMENT WITH 6 FILLS AND 6 DRAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491147 FRESENIUS PD +IQ CARD CYCLER (NEWTON IQ) FKX FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other