BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3123855 · Received May 15, 2013

    Report

    Report Number
    2937457-2013-00063
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW WAS PERFORMED OF THE MEDICAL RECORDS AND WRITTEN TREATMENT DATA BY THE POST MARKET CLINICAL DEPARTMENT AND PHYSICIAN AS PROVIDED BY THE PATIENT. THE REPORTED LARGE STAT DRAIN VOLUME RECORDED WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE PERITONEAL CYCLER (PLANT INVESTIGATION) IS CURRENTLY UNDERGOING EVALUATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED TECH SUPPORT AND STATED AIR BUBBLES WENT INTO HIM CAUSING DISCOMFORT AND HE CANCELED HIS CCPD TREATMENT. ADDITIONALLY, HE STATED THAT HE WAS EMPTY, WANTED TO STOP HIS FILL AND NEEDED ASSISTANCE WITH A STAT DRAIN. THE PATIENT PROVIDED THE FOLLOWING DRAIN INFORMATION OVER THE NEXT SEVERAL MINUTES. 515ML - 229ML - 1107ML - 1559ML - 1611ML 1874ML - 1925ML - 7738ML. WHEN THE DRAIN WAS COMPLETE, HE STATES HE HAD ONLY DRAINED APPROXIMATELY 2082ML EVEN THOUGH HE REPORTED THE LAST DRAIN OF 7738ML IN THE DRAIN SEQUENCE. HE WAS ADVISED BY TECH SUPPORT TO CANCEL HIS TREATMENT AND CONTACT HIS PD RN. ON (B)(6) 2013: THE PMC DEPARTMENT CONTACTED THE PATIENT'S PD RN WHO STATED HE WAS UNAWARE OF ANY LARGE DRAIN EVENTS THAT THE PATIENT MAY HAVE EXPERIENCED. HE ADDED THAT IT WAS EXTREMELY UNLIKELY THAT A DRAIN OF APPROXIMATELY 7700ML WOULD EVER OCCUR WITH THIS PATIENT. HE REVIEWED THE PATIENT'S HAND WRITTEN TREATMENT LOG AND BELIEVES REPORTED "LARGE DRAIN" WOULD HAVE BEEN THE "TOTAL" VOLUME FILLED FOR THE PD TREATMENT. HE ADDED THAT THERE WAS NO MEDICAL INTERVENTION DURING OR FOLLOWING THE EVENT OR SERIOUS INJURY. THE REPORTED LARGE STAT DRAIN EXCEEDS THE 180% DRAIN CRITERIA FOR A REPORTABLE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214877 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER - FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5% DEFLEX SOLUTION| 1.5% DEFLEX SOLUTION| LIBERTY CYCLER SET