BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/ STAY SAFE CYCLER SET

    MDR report key: 3596438 · Received January 22, 2014

    Report

    Report Number
    8030665-2014-00093
    Event Type
    Injury
    Date Received
    January 22, 2014
    Date of Event
    November 25, 2013
    Report Date
    December 23, 2013
    Manufacturer
    FRESENIUS MED CARE NORTH AMERICA
    Product Code
    KDJ
    PMA / PMN Number
    K9404806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE PLANT INVESTIGATION IS PENDING. THE POST MARKET SURVEILLANCE DEPARTMENT IS IN THE PROCESS OF REQUESTING MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED DIAGNOSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    CLINIC PERSONNEL REPORTED THAT DURING CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THE WHITE CONNECTOR ON FEMALE END OF TUBING CONNECTED TO THE SOLUTION BAGS WAS SLIDING OFF AND BECAME LOOSE. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2013 AND RECEIVED ANTIBIOTICS. THE SAMPLE WAS DISCARDED. THE PATIENT WAS CONTINUING ON CCPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53645 NEWTON IQ W/ STAY SAFE CYCLER SET KDJ FRESENIUS MED CARE NORTH AMERICA 13LR08090

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R FRESENIUS PERITONEAL DIALYSIS SOLUTION.| NEWTON CYCLER,