BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4095701 · Received September 5, 2014

    Report

    Report Number
    2937457-2014-02642
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION AND THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED OR REPLICATED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED. A BATCH RECORD REVIEW WAS CONDUCTED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCES. PRODUCT LABELING, MATERIAL, AND PROCESS CONTROLS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE CLINICAL INVESTIGATION INDICATES THE ALARM THAT OCCURRED DURING THE TREATMENT WERE RELATED TO PATIENT STARTING A TREATMENT BUT NOT CONNECTING HIMSELF TO THE CYCLER. THE EVENT HAS A POTENTIAL HARM OF INCONVENIENCE RELATED TO DELAY OF TREATMENT. NO INJURY OR DEVICE MALFUNCTION AS A RESULT. PATIENT DEVELOPED THE SCROTAL LEAK AT THE INITIATION OF PERITONEAL DIALYSIS ON (B)(6) 2012. PATIENT STOPPED PD AND DID HEMODIALYSIS FOR AN UNKNOWN PERIOD OF TIME. PATIENT RESUMED PD AND AGAIN DEVELOPED THE SCROTAL LEAK. PER PD NURSE AND REVIEW OF TECH SUPPORT CALL, THERE WERE NO CYCLER ISSUES OR MALFUNCTIONS ASSOCIATED WITH FILLS, DRAINS, OR OVERFILL EVENTS. THE FMC PHARMACOVIGILANCE PHYSICIAN CONCLUDES HERNIAS ARE A KNOWN COMPLICATION OF PERITONEAL DIALYSIS .THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A (B)(6) 2011 TO (B)(6) 2013.

    Description of Event or Problem · 1

    PATIENT'S WIFE CALLED TECH SUPPORT DUE TO AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0. PATIENT/USER OF THE FMC DIALYSIS DEVICE MENTIONS NOT COMPLETING THE PREVIOUS TREATMENT DUE TO NOT FEELING WELL. FOLLOW UP WITH THE PATIENT'S PERITONEAL DIALYSIS RN (PDRN) REVEALS THE PATIENT HAS A SCROTAL LEAK. ON (B)(6) 2012, PATIENT STARTS PERITONEAL DIALYSIS. SOON AFTER, PATIENT WAS DIAGNOSED WITH A SCROTAL LEAK. PATIENT THEN STOPPED PD AND STARTED HEMODIALYSIS. PATIENT WANTED TO ATTEMPT PD THERAPY AGAIN. PATIENT WAS ADVISED BY HIS DOCTOR AND PDRN THAT HE WAS AT HIGH RISK FOR THE SCROTAL LEAK TO DEVELOP AGAIN. PATIENT RESTARTED PERITONEAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543520 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PD SOLUTIONS| LIBERTY CYCLER TUBING SET