BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/ STAY SAFE CYCLER SET

    MDR report key: 4074134 · Received June 23, 2014

    Report

    Report Number
    8030665-2014-00500
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF ONE OF THE USE LINES DURING SET UP BECAUSE IT WAS NOT CLOSED. UPON FOLLOW UP, NURSE STATED THAT THE LEAK OCCURRED DURING TREATMENT AND THE NURSE ON THE SHIFT HAD PUSHED THE PIN IN AND IT BROKE. PATIENT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. PATIENT'S EFFLUENT HAS REMAINED CLEAR. SAMPLE IS NOT AVAILABLE, SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366251 NEWTON IQ W/ STAY SAFE CYCLER SET KDJ FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING 13PR08131

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER| PD SOLUTIONS