BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 6201029 · Received December 22, 2016

    Report

    Report Number
    2937457-2016-01255
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    January 18, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE OCCURRENCE DATE WAS UPDATED BASED ON MEDICAL RECORDS THERE IS NO DOCUMENTATION SUPPORTING A POSSIBLE ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT OF CARDIAC ARREST AND THE SUBSEQUENT EXPIRATION OF THE PATIENT. ALTHOUGH A TEMPORAL ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT CARDIAC ARREST AND THE SUBSEQUENT EXPIRATION EXIST, THE LIKELY ASSOCIATION IS THE PATIENT EXTENSIVE HISTORY OF COMORBIDITIES INCLUDING NONRHEUMATIC VALVE DISORDER, UNSPECIFIED AND DIABETES TYPE 2. ADDITIONALLY, THE ESRD DEATH NOTIFICATION LIST THE PRIMARY CAUSE OF DEATH AS CARDIAC ARREST, CAUSE UNKNOWN; SECONDARY CAUSE OF DEATH: ATHEROSCLEROTIC HEART DISEASE AND CARDIOMYOPATHY. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, 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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT HAD A MYOCARDIAL INFARCTION AND EXPIRED WHILE ON CONTINUOUS CYCLER ASSISTED PERITONEAL DIALYSIS THERAPY. ADDITIONAL INFORMATION HAS BEEN SOLICITED.

    Description of Event or Problem · 1

    THE PATIENT WAS DISCONNECTED FROM HIS CYCLER AND TRANSPORTED TO A HOSPITAL, WHERE HE WAS PRONOUNCED DECEASED. FOLLOWUP WITH THE PATIENT'S CLINIC DIRECTOR REVEALED NO INDICATION THAT THE PATIENT'S PD CYCLER WAS ALARMING OR MALFUNCTIONING ON THE NIGHT OF THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850895 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DELFLEX PD SOLUTIONS| LIBERTY CYCLER SET