BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 1352447 · Received January 5, 2009

    Report

    Report Number
    8030665-2009-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2009
    Date of Event
    December 8, 2008
    Report Date
    January 5, 2009
    Manufacturer
    C D REYNOSA
    Product Code
    KDJ
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: NO INDICATION OF THE REPORTED DEFECT FOUND DURING DHR REVIEW. THE LOT MEETS ALL RELEASED CRITERIA. SAMPLE ANALYSIS: THE SAMPLE WAS NOT AVAILABLE FOR AN EVALUATION. CONCLUSION: THE REPORTED DEFECT IS NOT CONFIRMED. FMC REYNOSA WILL CONTINUE TO MONITOR THIS TYPE OF DEFECT PER CURRENT PROCEDURE. SINCE THE COMPLAINT WAS NOT CONFIRMED, NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME RELATED TO THIS EVENT. FMC NA WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT HAS BEEN RECEIVED FROM A PATIENT. IT HAS BEEN LEARNED IN SPEAKING WITH THE WIFE OF THE PATIENT, THAT THE PATIENT RECEIVED ONE DOSE OF INTRAPERITONEAL ANTIBIOTIC FOR POSSIBLE CONTAMINATION. THE PATIENT REPORTED THAT HE CONNECTED TO THE 1ST CONNECTOR ON THE TREATMENT SET, WHEN HE NOTICED SOME LEAKING. HE THEN DISCONNECTED FROM THE 1ST CONNECTOR AND CONNECTED TO THE 2ND CONNECTOR ON THIS SET. REPORTEDLY, THE SECOND CONNECTOR WAS NOT LEAKING. IT WAS RECOMMENDED THAT HE CONTACT HIS CLINIC DUE TO POSSIBILITY OF A CONTAMINATION. THE PATIENT IS ABLE TO CONTINUE PD AS PRESCRIBED AND CULTURE RESULTS ARE PENDING. THE SAMPLE HAS BEEN THROWN OUT. THE PATIENT HAS ALSO BEEN ENCOURAGED TO SAVE SAMPLES IF POSSIBLE IN THE FUTURE. THE RN WHO PROVIDES THE CARE OF THIS PATIENT REPORTED THAT TO DATE, NO PERITONITIS HAS DEVELOPED, AND THAT THE PATIENT IS FINE AND ABLE TO CONTINUE PERITONEAL DIALYSIS AS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TUBING SET KDJ C D REYNOSA NA 8PR003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA