BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 839696 · Received April 19, 2007

    Report

    Report Number
    8030665-2007-00027
    Event Type
    Malfunction
    Date Received
    April 19, 2007
    Date of Event
    March 26, 2007
    Report Date
    April 19, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REC'D AN ELECTRONIC REPORT FROM A PERITONEAL DIALYSIS RN WHO REPORTED THE SECOND CONNECTOR ON THE TUBING SET LEAKED. IT WAS LEARNED THE MACHINE ALARMED AND THE PT PUT THE LIGHT ON IN THE ROOM, AND THEN NOTICED THE MATTRESS WAS ALL WET AND THAT THE TUBING SET LEAKED OUT FROM THE SECOND CONNECTOR. AS A RESULT, THE PT NOTIFIED THE RN AND THEN CAME INTO THE CLINIC, HAD A CULTURE DONE, HAD A NEW CATHETER EXTENSION SET APPLIED AND WAS PRESCRIBED A PROPHYLACTIC PRESCRIPTION OF CIPRO 4 TABS PO FOR 2 DAYS. TO DATE THIS PT DENIES ANY SIGNS OR SYMPTOMS OF INFECTION. THE PT BROUGHT THE TUBING SET INTO THE CLINIC ALONG WITH A COMPANION SAMPLE. HOWEVER, THE RN EXAMINED THE TUBING SET, REMOVED THE PROTECTIVE OVERWRAP COVERING THE SECOND CONNECTOR AND NOTICED THE CONNECTION WAS LOOSE. SHE THEN DISCARDED THE SET BECAUSE IT WAS USED. SHE WILL SEE IF SHE CAN LOCATE IT. SHE WILL FORWARD BOTH SAMPLES FOR EVAL IF POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TUBING SET FJK REYNOSA MANUFACTURING NA 6PR014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR