BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/STAY CYCLER SET

    MDR report key: 842246 · Received April 19, 2007

    Report

    Report Number
    8030665-2007-00029
    Event Type
    Injury
    Date Received
    April 19, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 19, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    k811986
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN ELECTRONIC REPORT FROM A PERITONEAL DIALYSIS PATIENT WHO HAS REPORTED WHEN HE DISCONNECTS THE BLUE PIN IS NOT ENGAGED IN THE CATHETER AND THE PIN FELL ON THE FLOOR. THE PT WAS CALLED AND HIS WIFE PROVIDED ADDITIONAL DETAILS ON THIS EVENT. ACCORDING TO THEM, THE PIN LOOKED ENGAGED OR SEATED AND WHEN THEY DISCONNECTED, THE PIN CAME OUT OF THE CATHETER. THE PT SCREWED A CAP ON THE CATHETER END TO CLOSE IT. ALSO REPORTED WAS THAT AT THAT TIME, THERE WAS VERY LITTLE OR NO DRAINAGE OF EFFLUENT. IN 2007, THE PT WAS STARTED ON VANCOMYCIN IP FOR PERITONITIS. THE PT'S RN WAS CONTACTED AND ACCORDING TO HER, THIS PT WAS CLAMPING BOTH THE PD TUBING SET AS WELL AS CATH EXT SET AND AS A RESULT THE BLUE PIN WILL NOT ENGAGE. SHE ALSO REPORTED HE HAS A LOW ALBUMIN AND HAS EDEMA AND IS HOLDING ON TO EXTRA FLUID. SHE ALSO NOTED FIBRIN WAS PRESENT IN THE EFFLUENT AND WAS ALSO CLOUDY WITH POOR DRAINAGE. A CULTURE WAS OBTAINED AND VANCOMYCIN WAS PRESCRIBED AND ADMINISTERED IP AT THAT TIME. THE PT WAS ADMITTED TO THE HOSPITAL FOR NO DRAINAGE THREE DAYS LATER AND IS NOW ON HEMODIALYSIS. THE PT UNDERWENT SURGERY FOR POOR DRAINAGE. IT WAS REPORTED SCAR TISSUE WAS REMOVED BUT APPEARS TO BE COMING BACK. IS CURRENTLY ON IV VANOCYMCIN AND ON HEMODIALYSIS AND IS IMPROVING. SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY CYCLER SET PD TUBING SET FJK REYNOSA MANUFACTURING NA 6SR002

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| O| R