BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4858458 · Received June 19, 2015

    Report

    Report Number
    2937457-2015-01202
    Event Type
    Death
    Date Received
    June 19, 2015
    Date of Event
    January 28, 2015
    Report Date
    May 21, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. BASED ON THE 2 PAGES OF MEDICAL RECORDS INFO, IT APPEARS THAT ON (B)(6) 2015 THE PT EXPIRED. ACCORDING TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PT PASSED AWAY FROM HEART PROBLEMS NOT CYCLER RELATED. THE PDRN STATED THAT THE PT PASSED AWAY WHILE CONNECTED TO THE CYCLER. THE DEATH CERTIFICATE INDICATES THAT THE CAUSE OF DEATH WAS HEART FAILURE WITH RENAL DISEASE AS A CONTRIBUTING FACTOR. THE MEDICAL RECORDS DO NOT CONTAIN AN AUTOPSY REPORT AS IT IS NOT NOTED IN THE DEATH CERTIFICATE. MEDICAL RECORDS DO NOT CONTAIN DIALYSIS FLOW RECORDS, PROGRESS NOTES, DIALYSIS NOTES OR LAB/DIAGNOSTIC REPORTS FOR REVIEW. THE DECEDENT'S DIALYSIS WAS NOT INDICATED AS A CAUSE FOR HIS DEMISE. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORDS THAT SHOWS ANY CASUAL RELATIONSHIP BETWEEN THE PT'S PERITONEAL DIALYSIS AND HIS DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT FAILURE. THERE WERE INDICATIONS OF COCKROACH SPECKS ON THE HEATER TRAY AND WITHIN THE CASSETTE COMPARTMENT. THERE WERE NO BURRS OR SHARPS IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THE VALVE ACTUATION TEST PASSED. THE SYSTEM AIR LEAK TEST PASSED. THE LOAD CELL VERIFICATION WAS WITHIN TOLERANCE. THE CYCLER PASSED THE MUSHROOM HEADS CHECK. THE INTERNAL INSPECTION OF THE CYCLER FOUND VISUAL EVIDENCE OF DISCOLORATION ON THE PNEUMATIC LINES. THE SYSTEM LEVEL REVIEW OF THE LIBERTY CYCLER AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO THE CLINICAL EVENT. IT WAS NOTED THE PATIENT EXPIRED ON (B)(6) 2015 AND THE DEVICE WAS STORED AT PATIENT'S BROTHER'S HOME UNTOUCHED AND UNUSED UNTIL IT WAS DELIVERED BACK TO THE NURSE ON (B)(6) 2015. THE DEVICE WAS RETURNED TO THE MANUFACTURE FOR EVALUATION ON 08/13/2015. IT WAS RETURNED COVERED IN MOLD FROM BEING POORLY STORED AWAY. THE DEVICE WAS NOT MOLDY DURING THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED A PT EXPIRED WHILE UNDERGOING PERITONEAL DIALYSIS TREATMENT WITH THE LIBERTY CYCLER. THE PT EXPIRED AT HOME ON (B)(6) 2015. DEATH CERTIFICATE INDICATED THE PT'S CAUSE OF DEATH WAS HEART FAILURE WITH RENAL DISEASE AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400484 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PD SOLUTION.