BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PT CONNECT

    MDR report key: 1615031 · Received February 22, 2010

    Report

    Report Number
    8030665-2010-00003
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 22, 2010
    Manufacturer
    C D REYNOSA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THERE IS NO PRODUCT DEFECT INDICATED BY THE REPORTER OF THIS EVENT.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A PERITONEAL DIALYSIS NURSE WHO HAS REPORTED AN EVENT WITH THE USE OF THIS PRODUCT. IT WAS INITIALLY REPORTED: ABDOMINAL PAIN, CHEST PAIN AND PAIN RADIATING TO HIS SHOULDER RESULTING IN AN ER VISIT. A CHEST X-RAY AND CT SCAN WERE PERFORMED AND THE CT SCAN RESULTS INDICATED FREE AIR UNDER THE DIAPHRAM AND IN THE PERITONEAL CAVITY. A CALL WAS PLACED TO THIS FACILITY FOR ADD'L INFO. IN SPEAKING WITH THE NURSE, IT WAS LEARNED THAT THE PT WAS DISCHARGED TO HOME ON THE SAME DAY WITH PAIN PILLS AND REPORTEDLY IS DOING FINE. ADDITIONALLY, THE NURSE REPORTED THIS PT HAS RECENTLY STARTED TO USE THIS PRODUCT. SHE ALSO WAS NOT ABLE TO IDENTIFY OR SAY WHAT WAS WRONG WITH THE PRODUCT BUT WANTED TO REPORT THIS EVENT. THERE IS NO SAMPLE AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O