BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 1892387 · Received October 28, 2010

    Report

    Report Number
    8030665-2010-00033
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    July 2, 2010
    Report Date
    October 28, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S WIFE HAS REPORTED THAT HER HUSBAND HAS HAD PERITONITIS THIS PAST YEAR. THE CLINIC WAS CONTACTED FOR ADDITIONAL INFORMATION ON THIS INCIDENT. IN SPEAKING WITH THE NURSE, IT WAS CONFIRMED THAT THE PATIENT HAD PERITONITIS. THE DAY OF DIAGNOSIS WAS ON (B)(6) 2010. IT WAS ALSO REPORTED THAT THE PATIENT HAS FULLY RECOVERED FROM THIS EVENT. THE PATIENT WAS TREATED ON AN OUT PATIENT BASIS. ADDITIONALLY, THE RN STATED THAT THE PATIENT HAD NEVER MENTIONED OR REPORTED ANY LEAKS OR PROBLEMS WITH USE OF THIS SET. THERE IS NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R LIBERTY CYCLER PERITONEAL DIALYSIS| MACHINE