BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 5999635 · Received October 5, 2016

    Report

    Report Number
    2937457-2016-01071
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 1, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER PROGRAMMED DISPLAYED FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. A SECOND SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE. THE CYCLER PROGRAMMED DISPLAYED. FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. THE VALVE ACTUATION TEST PASSED. THE SYSTEM AIR LEAK TEST PASSED. THE LOAD CELL VALUE AND VERIFICATION WERE WITHIN TOLERANCE. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THERE WAS VISUAL EVIDENCE OF DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. PASSED MUSHROOM HEAD CHECK. IN ADDITION, THE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT'S CONTACT REPORTED THAT THE PATIENT PASSED AWAY WHILE CONNECTED TO THERAPY. THE CAREGIVER REPORTED THAT SHE HEARD THE PATIENT MOANING AT 0500 HRS, FOUND THE PATIENT HAD BEEN INCONTINENT AND WAS RESPONSIVE. A FEW HOURS LATER THE CAREGIVER RETURNED TO DISCONNECT THE PATIENT AND FOUND HER UNRESPONSIVE. THE EMERGENCY MEDICAL SERVICES WERE CALLED AND THEY WERE UNABLE TO RESUSCITATE THE PATIENT. DURING FOLLOW UP WITH THE PATIENT'S NURSE IT WAS REPORTED THE PATIENT'S CAUSE OF DEATH WAS HER CHRONIC ILLNESSES. THE NURSE ALSO REPORTED THAT THE PATIENT HAD COMPLAINED OF SHOULDER PAIN THE PREVIOUS NIGHT BEFORE CONNECTING TO THE CYCLER FOR PERITONEAL DIALYSIS TREATMENT. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650700 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DELFLEX PD SOLUTIONS