BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 1901557 · Received November 12, 2010

    Report

    Report Number
    8030665-2010-00042
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS REC'D FROM A PERITONEAL DIALYSIS PT: HE HAS REPORTED LEAKING FROM CASSETTE. NOTICED THE NEXT MORNING. WILL PROVIDE 1 SAMPLE FOR EXAMINATION AND THAT IS ALL. BECAME ILL DAY AFTER USE AND BELIEVES TUBING IS TO BLAME. WENT FOR MEDICAL TREATMENT FOR A PERIOD OF 1 WEEK. THE PT'S CLINIC WAS CALLED FOR ADD'L INFO ON THE EVENT. IN SPEAKING WITH THE NURSE, IT WAS LEARNED THAT THE PT HAD STARTED PD (B)(6) 2009. IT WAS CONFIRMED THAT THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND DISCHARGED 7 DAYS LATER. THE NURSE REPORTED HE HAD A "HORRIBLE" HOSPITAL ADMISSION. REPORTEDLY THE PT HAD ALTERED MENTAL STATUS DUE TO UREMIA. ALSO, THE PD CATH HAD TO BE REMOVED AND THE PT WAS STARTED ON HEMODIALYSIS. CURRENTLY, THIS PT HAS REC'D A TRANSPLANT AND IS OFF DIALYSIS. NO FURTHER RECORDS OR INFO REGARDING THIS INCIDENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE PATIENT CONN PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA 09SR08038

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O| R LIBERTY CYCLER DIALYSIS MACHINE