BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SALE CYCLER SET

    MDR report key: 806829 · Received January 8, 2007

    Report

    Report Number
    8030665-2007-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2007
    Date of Event
    December 5, 2006
    Report Date
    January 8, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN ELECTRONIC REPORT FROM AN EVENT. IT WAS REPORTED THAT, A PERITONEAL DIALYSIS PT CONNECTED HERSELF ON THE FIRST CONNECTOR OF THE PD TUBING SET AND WAS UNDERGOING TREATMENT. SHE HAD FALLEN ASLEEP AND WHEN SHE WOKE UP, FOUND A DRIP FROM THE SECOND CONNECTOR AND APPROX 30 ML OF DIALYSATE ON THE FLOOR. THE PT NOTIFIED THE CLINIC THE FOLLOWING DAY. IT WAS REPORTED HER EFFLUENT HAS REMAINED CLEAR, NOR DID SHE DEVELOP ANY PERITONITIS SYMPTOMS. SHE WAS INSTRUCTED TO GO TO THE CLINIC FOR FURTHER EVALUATION OF THIS EVENT. A CELL COUNT AND CULTURE WAS ORDERED AND OBTAINED. THE PT ALSO WAS ADMINISTERED A PROPHYLACTIC DOSE OF VANCOMYCIN 1 GRAM AND GENTAMYCIN 80 MG IP. IT HAS SINCE BEEN LEARNED THAT, THE RESULTS OF THE CULTURE WERE NEGATIVE. THE PT DID NOT DEVELOP PERITONITIS. A SAMPLE IS AVAILABLE FOR EVALUATION. REPORTEDLY, THIS PT CONTINUES PERITONEAL DIALYSIS AS ORDERED WITH NO FURTHER ILL EFFECT RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SALE CYCLER SET PD TUBING SET FJK REYNOSA MANUFACTURING NA 6HR148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA