BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4911459 · Received July 10, 2015

    Report

    Report Number
    2937457-2015-01260
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 10, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON POST MARKET CLINICAL INVESTIGATION OF THE AVAILABLE MEDICAL RECORDS, IT APPEARS THAT ON (B)(6) 2015, THE PT WAS FOUND DEAD IN THE BATHROOM. THE PT WAS NOT ON DIALYSIS AT THE TIME OF THE EVENT. THE PT HAD BEEN BATTLING INCREASED SHORTNESS OF BREATH AND LOW BLOOD PRESSURE AND THE DIALYSIS CENTER WAS UNABLE TO PULL OFF FLUID ON PERITONEAL FLUID. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE EVENT WAS BROUGHT TO HER ATTENTION AND THAT THERE WAS NO APPARENT EFFECT CAUSED BY THE REPORTED EVENT. PDRN REPORTED THAT THE PT PASSED AWAY ON (B)(6) 2015 OF A HEART ATTACK. ACCORDING TO THE PDRN, THE PT WAS ALLEGED TO HAVE NOT BEEN ON TREATMENT AT THE TIME OF HIS HEART ATTACK. PDRN REPORTED THAT THE PT WAS PREPARING TO ENTER HOSPICE CARE FOR THE CONDITION OF A WEAK HEART AND LUNGS; HE HAD ENTERED A BATHROOM TO URINATE AND EXPERIENCED A HEART ATTACK IN THE BATHROOM. PT'S SPOUSE FOUND HIM AND INFORMED THE FACILITY OF HIS PASSING. THERE WERE NO LAB OR DIAGNOSTIC RESULTS, AUTOPSY REPORT, DEATH CERTIFICATE, PROGRESS NOTES, TREATMENT RECORDS OR FLOW RECORDS IN THE MEDICAL RECORDS FOR REVIEW. THERE WAS NO DOCUMENTATION IN THE MEDICAL RECORDS THAT INDICATE A CAUSAL RELATIONSHIP BETWEEN THE PT'S DEATH AND THE PT'S LIBERTY CYCLER.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF ANY PHYSICAL DAMAGE. THE HEATER TRAY/SCALE WAS NOT OBSTRUCTED. TWO SIMULATED TREATMENTS WERE PERFORMED USING THE RECEIVED CYCLER, AND THERE WERE NO ALARMS OR PROBLEMS THAT OCCURRED DURING TESTING. ONE OF THE SIMULATED TREATMENTS WAS PERFORMED IN WHICH THE WEIGHTED FILL VOLUMES FROM EACH CYCLE WERE COMPARED TO THE PROGRAMMED FILL VOLUMES. THE DELIVERED FILL VOLUMES WERE WITHIN THE TOLERANCE FOR THIS DEVICE. THE VALVE ACTUATION TEST PASSED. THE SYSTEM AIR LEAK TEST PASSED. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THE LOAD CELL VERIFICATION WAS WITHIN TOLERANCE. 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 NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE MANUFACTURING REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A FOLLOW-UP WILL BE SUBMITTED FOLLOWING REVIEW BY THE POST MARKET CLINICAL DEPARTMENT.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED THAT THE PATIENT HAD PASSED AWAY OF A HEART ATTACK. IT WAS FURTHER STATED THAT THE PATIENT WAS NOT ON TREATMENT AT THE TIME OF PASSING. DURING FOLLOW UP THE PATIENT'S NURSE REPORTED THAT HE HAD BEEN FOUND UNRESPONSIVE ON HIS BATHROOM FLOOR. HE HAD BEEN PREPARING TO ENTER HOSPICE DUE TO DETERIORATING HEALTH INCLUDING SHORTNESS OF BREATH, LOW BLOOD PRESSURE, AND AN INABILITY TO ACHIEVE ADEQUATE DIALYSIS DUE TO THE LOW BLOOD PRESSURE. ADDITIONAL MEDICAL RECORDS WERE REQUESTED BUT WERE NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448918 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death PD FLUID| MIDODRINE