BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3133050 · Received May 24, 2013

    Report

    Report Number
    2937457-2013-00067
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    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 INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL AND PLANT INVESTIGATIONS. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR # 8030665-2013-00323.

    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 STATED THAT DURING TREATMENT THERE WAS AN AIR IN CASSETTE LEAK ERROR. PT HAS MENTIONED THAT THEY NOW HAVE PERITONITIS. PT IS UNSURE IF THIS WAS A RESULT OF THIS 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 RECEIVED; PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231660 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R LIBERTY CYCLER TUBING SET| PD SOLUTION