BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 5260847 · Received November 25, 2015

    Report

    Report Number
    2937457-2015-01663
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 31, 2015
    Report Date
    November 25, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS NOT CONFIRMED. THE EXTERIOR OF THE CYCLER SHOWS NO PHYSICAL DAMAGE. DURING THE SIMULATED TREATMENT OF THE DEVICE THE MACHINE PASSED ALL TEST PERFORMED WITHOUT ANY FAILURES OR PROBLEMS. THERE WERE NO DISCREPANCIES ENCOUNTERED IN THE INTERNAL INSPECTION OF THE CYCLER. 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 DHR REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PERITONEAL DIALYSIS (PD) PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON PD THERAPY, REPORTED HE EXPERIENCED DRAIN COMPLICATION ON (B)(6) 2015. DURING TREATMENT DATA REVIEW THE PATIENT EXPERIENCED MODERATE AND MILD INCREASED INTRAPERITONEAL VOLUME (IIPV). UPON FOLLOW-UP, A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) NURSE CONFIRMED THE PATIENT ISSUES OF MODERATE AND MILD (IIPV) ASSOCIATED WITH FEELING BLOATED RESOLVED. THE PDRN STATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS NOR NEED MEDICAL INTERVENTION. THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITH THE CYCLER WITHOUT FURTHER ISSUE. A PERITONEAL DIALYSIS (PD) PATIENT REPORTED HE HAD EXPERIENCED DRAIN ISSUES DURING TREATMENT. THE PATIENT REMAINED ASYMPTOMATIC: DRAIN 0: 2ML. FILL 1: 2216ML DRAIN 1: 1979ML, FILL 2: 2203ML DRAIN 2: 1995ML, FILL 3: 2196ML DRAIN 3: 1800ML, FILL 4: 2203ML DRAIN 4: 4138ML, FILL 5: 2203ML LAST FILL VOLUME. THE REPORTED DRAIN VOLUME OF 4138 WAS 188% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE OVERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781394 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR