BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3133042 · Received May 24, 2013

    Report

    Report Number
    8030665-2013-00323
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS HAVE BEEN RECEIVED BY THE MANUFACTURER. AT THE CONCLUSION OF THE CLINICAL INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL INVESTIGATION. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVAL, HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR # 2937457-2013-00067.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT MENTIONED THAT THEY NOTICED MOISTURE ON THE PUMP HEADS. PT HAS MENTIONED THAT THEY NOW HAVE PERITONITIS. PT IS UNSURE IF THIS WAS A RESULT OF THE LEAK. RN CONFIRMED THAT PT HAD PERITONITIS AND PD CULTURES WERE DRAWN AND WERE POSITIVE. PT RECEIVED ANTIBIOTICS, AND THE LAST DOSE WAS ON (B)(6) 2013. THE PERITONITIS HAS RESOLVED; PT IS FINE. COMPANION SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232789 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13BR08927

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R LIBERTY DIALYSIS CYCLER