BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SET, SINGLE CONN./EXT. D

    MDR report key: 2160620 · Received July 6, 2011

    Report

    Report Number
    8030665-2011-00032
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OF NOTE: MINIMAL INFORMATION REGARDING THIS INCIDENT WAS RECEIVED ON (B)(4) 2011. ALL THE INFORMATION GATHERED WAS CLARIFIED AND THE CORRECT PRODUCT WAS IDENTIFIED ON (B)(4) 2011. THERE HAS BEEN NO REPORT OF A PRODUCT PROBLEM/DEFECT. EVENT MAY HAVE BEEN THE RESULT OF PATIENT SELF CONTAMINATION.

    Description of Event or Problem · 1

    AN INITIAL REPORT WAS RECEIVED STATING THAT A PERITONEAL DIALYSIS PATIENT HAD DEVELOPED PERITONITIS AND MAY POSSIBLY BE ASSOCIATED WITH THE USE OF OUR PRODUCT. IN SPEAKING WITH THE PATIENT FOR CLARIFICATION OF THE EVENT, IT WAS LEARNED THAT SHE IS NEW TO THIS PRODUCT LINE HAVING HAD HER FIRST TRAINING SESSION ON (B)(6), 2011. ON THE DAY OF THE EVENT (B)(6), 2011, SHE ATTEMPTED TO CONNECT THE PIN BUT "DIDN'T DO THE PIN RIGHT". THE PATIENTS PD NURSE CONFIRMED THAT THERE WAS NO PRODUCT MALFUNCTION BUT THE PATIENT "MADE SOME KIND OF ERROR IN CONNECTING THAT RESULTED IN CONTAMINATION". THE PATIENT DEVELOPED SYMPTOMS OF ABDOMINAL PAIN, VOMITING AND DIARRHEA AND WAS ADMITTED TO THE HOSPITAL ON (B)(6), 2011 WITH A DIAGNOSIS OF PERITONITIS. SHE WAS DISCHARGED ON (B)(6), 2011 AND IS CURRENTLY RECEIVING DIALYSIS WITH A DIFFERENT PRODUCT LINE AND IS REPORTEDLY DOING WELL. THERE IS NO SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SET, SINGLE CONN./EXT. D PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MANUFACTURING NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R