BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/ STAY SAFE CYCLER SET

    MDR report key: 1302189 · Received January 30, 2009

    Report

    Report Number
    8030665-2009-00006
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    December 31, 2008
    Report Date
    January 29, 2009
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K811986
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A PERITONEAL DIALYSIS UNIT THAT REPORTED A PINHOLE LEAK CAUSED AN EPISODE OF PERITONITIS. THE RN WAS CONTACTED FOR INFORMATION REGARDING THIS EVENT. IT HAS BEEN LEARNED THAT THE PT HAD USED THESE LINES, AND AFTER HE CAME OFF THE CYCLER, HE HAD NOTICED HIS FLOOR WAS WET. HE FOLLOWED THE FLUID PATH AND FOUND THAT THE FLUID HAD COME OUT OF A PINHOLE AT THE PUMP SEGMENT. THE RN STATED THAT ABOUT 6 HOURS LATER, THIS PT DEVELOPED ABDOMEN PAIN AND HAD CLOUDY BAGS (EFFLUENT). THE PT HAD COME INTO THE CLINIC FOR EVALUATION. AT THAT TIME, A SAMPLE OF THE EFFLUENT WAS OBTAINED FOR A CULTURE. THE RESULTS OF THE CULTURE HAD INDICATED NO GROWTH, HOWEVER THE RN SAW THE CLOUDY BAGS AND TREATED THE PT PER PROTOCOL. AS A RESULT, THE PT RECEIVED INTRAPERITONEAL ANTIBIOTICS FOR PERITONITIS FOR THIS EVENT. THE PT HAS SAVED THE SAMPLE AS ADVISED BY THE RN. ADDITIONALLY, IT HAS BEEN LEARNED THAT THE PT IS FINE AND IS ABLE TO CONTINUE PERITONEAL DIALYSIS AS ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/ STAY SAFE CYCLER SET PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA 8LR114

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R