BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS PD+ IQ CARD CYCLER (NEWTON IQ)

    MDR report key: 4110276 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02677
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K002892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED NEWTON CYCLER COMPLETED THE SIMULATED TREATMENT WITHOUT ERROR OR WARNING. NO FLUID LEAKS WERE OBSERVED. THE REPORTED SYMPTOMS OF EMPTYING ALARM AND FLUID LEAKING WERE NOT CONFIRMED DURING TESTING. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN (B)(4) 2011 TO (B)(4) 2013.

    Description of Event or Problem · 1

    HOME PERITONEAL DIALYSIS PT REPORTED THAT DURING DRAIN 2, SOLUTION WAS LEAKING FROM THE NEWTON CYCLER. PT WAS ADVISED BY HIS NURSE TO RESET UP. IN DWELL 3 THE CYCLER WAS GIVING EMPTYING ALARM AND WAS NOT EMPTYING THE WEIGH BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559830 FRESENIUS PD+ IQ CARD CYCLER (NEWTON IQ) NEWTON IQ KX FKX FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON NA

    Patients

    Seq Age Sex Outcome Treatment
    1