BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4112612 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02682
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    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

    AN INVESTIGATION WAS PERFORMED FOR THIS DEVICE. A VISUAL INSPECTION SHOWED NO PHYSICAL EXTERIOR DISCREPANCIES. ALL FUNCTIONAL TESTS PASSED. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITH NO ISSUES OR NO ALARMS. THE REPORTED SYMPTOMS WERE NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THERE WERE NO UNEXPLAINED VARIANCES, ADJUSTMENTS OR COMMENTS NOTED IN THE DEVICE RECORDS. A REVIEW OF THE COMPLAINT TRACKING SYSTEM LISTED NO OTHER COMPLAINTS FOR THE REPORTED SYMPTOMS FOR THIS DEVICE. A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPT. PER THE PHARMACOVIGILANCE PHYSICIAN, THE PERITONITIS EVENT PRE-DATES THE USE OF THE CYCLER AND NOT ATTRIBUTED TO THE CYCLER USE. IT IS USUALLY DUE TO TOUCH CONTAMINATION. IT IS NOT UNUSUAL FOR PATIENTS TO HAVE BLOOD TINGED EFFLUENT DUE TO LIFTING, STRAINING OR BROKEN BLOOD VESSELS IN THE PERITONEUM. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN (B)(6) 2011 TO (B)(6)2013.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PERITONEAL DIALYSIS PT'S SON CALLED FRESENIUS TECH SUPPORT STATING THAT THIS IS THEIR VERY FIRST NIGHT WITH THE CYCLER AND THE PAT HAD A M71.2 PRESSURE LEAK AFTER COMPLAINING OF CRAMPING. HE THE STATED THAT HIS FATHER'S DRAIN BAG WAS FULL OF BLOOD. TECH SUPPORT ADVISED HIM TO POWER DOWN THE CYCLER AND CALL THE DOCTOR IMMEDIATELY, HE AGREED AND HUNG UP. TECH SUPPORT CALLED THEM BACK AT 01:49 AND SPOKE WITH THE PT'S DOCTOR WHO ADVISED THE SON TO WATCH HIS DAD CLOSELY AND IF IT GOT ANY WORSE TO GO TO EMERGENCY. THE SON STATED THE DOCTOR THINKS THE PT MAY HAVE A SMALL TEAR IN HIS INTESTINE, THE PT HAS AN APPOINTMENT TOMORROW AND THE CLINIC TOLD HIM TO BRING IN THE CYCLER AND THEY WOULD GIVE HIM A REPLACEMENT. I INFORMED THE PT I COULD REPLACE IT BUT THEY STATED THAT THE CLINIC WOULD BE GIVING THE PT A NEW CYCLER. TECH SUPPORT SPOKE WITH THE PT AND HE WAS FEELING OK. DURING F/UP IT WAS LEARNED THE PT HAD PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559527 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS SYSTEM FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R