BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 1231113 · Received October 30, 2008

    Report

    Report Number
    8030665-2008-00047
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 30, 2008
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS RN HAS REPORTED AN EVENT THAT OCCURRED TO A PATIENT RECEIVING CARE FROM HER UNIT. IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE CYCLER UNDERGOING TREATMENT, WHEN ON THE NIGHT SOMETIME IN 2008, WAS AWAKENED BY FLUID IN THE BED. THE PATIENT HAD DISCOVERED A LEAK IN THE TREATMENT SET, COMING FROM THE 2ND SECTION OF THE PIN CONNECTOLOGY. WHEN THE PATIENT DETECTED THIS EVENT, THE TREATMENT WAS DISCONTINUED. THE PATIENT WAS EVALUATED FOR A POSSIBLE CONTAMINATION AT THE CLINIC IN THE MORNING OF THE NEXT DAY. THIS PATIENT RECEIVED ONE INTRAPERITONEAL PROPHYLACTIC DOSE OF ANTIBIOTICS FOR CONTAMINATION. THE RN HAS VERBALLY REPORTED THAT THE PATIENT IS FINE AND DID NOT SUFFER ANY ILL EFFECT OR REQUIRE ANY ADDITIONAL MEDICAL TREATMENT CAUSED FROM THIS EVENT. THIS PATIENT IS ABLE TO CONTINUE PERITONEAL DIALYSIS AS ORDERED. THE SAMPLE IS AVAILABLE FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TREATMENT TUBING SET FKX REYNOSA MANUFACTURING NA 8ER287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA