BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY SELECT CYCLER

    MDR report key: 7327123 · Received March 9, 2018

    Report

    Report Number
    2937457-2018-00735
    Event Type
    Death
    Date Received
    March 9, 2018
    Date of Event
    January 16, 2018
    Report Date
    March 29, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION: A TEMPORAL ASSOCIATION EXISTS BETWEEN CCPD THERAPY WITH THE LIBERTY SELECT CYCLER AND THE PATIENT¿S ADVERSE EVENT(S) OF ABDOMINAL PAIN WHICH REQUIRED HOSPITALIZATION RELATED TO SMALL BOWEL OBSTRUCTION AND GASTROINTESTINAL HEMORRHAGE. DURING HOSPITALIZATION, THE PATIENT WAS TRANSITIONED TO HD THERAPY (UNKNOWN PRODUCTS AND TREATMENT DETAILS). SUBSEQUENTLY THE PATIENT¿S HEALTH STATUS CONTINUED TO DECLINE WITH SIGNIFICANT HYPOTENSION AND CARDIAC ARRHYTHMIAS, AND ON (B)(6) 2018 THE PATIENT EXPIRED. BASED ON THE AVAILABLE INFORMATION, THE ETIOLOGY FOR THE PATIENT¿S SBO AND GASTROINTESTINAL HEMORRHAGE IS UNKNOWN. IT IS KNOWN THAT PATIENTS WITH ESRD ON PD THERAPY MAY DEVELOP GASTROINTESTINAL COMPLICATIONS SUCH AS SMALL BOWEL OBSTRUCTION AND GASTROINTESTINAL HEMORRHAGE. THEREFORE, IT IS POSSIBLE CCPD THERAPY WITH THE LIBERTY SELECT CYCLER MAY HAVE BEEN A POTENTIAL FACTOR IN THE PATIENT¿S SBO AND GASTROINTESTINAL HEMORRHAGE EVENT. HOWEVER, AT THE TIME OF THIS CLINICAL INVESTIGATION, THERE HAVE BEEN NO REPORTED ALLEGATIONS AGAINST OR DOCUMENTATION THAT INDICATES THE LIBERTY SELECT CYCLER MALFUNCTIONED IN ANY WAY TO CAUSE OR CONTRIBUTE TO THE EVENT. FURTHERMORE, THE HOSPITAL DISCHARGE SUMMARY STATES THE PRELIMINARY CAUSE OF DEATH AS SBO, WITH SECONDARY CAUSE LISTED AS ESRD. HOWEVER, THE PATIENT¿S ESRD DEATH NOTIFICATION OR DEATH CERTIFICATE IS NOT AVAILABLE AT THIS TIME AND THEREFORE ACTUAL CAUSE OF DEATH CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CLINICAL INVESTIGATION WILL BE RE-EVALUATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM FAILURE MODE. A SERIAL NUMBER REVIEW COULD NOT BE PERFORMED AS NO SERIAL NUMBER WAS AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A PERITONEAL DIALYSIS PATIENT HAD EXPIRED. UPON FURTHER FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT STATED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 FOR BOWEL OBSTRUCTION. THE TREATMENT RENDERED AT THE HOSPITAL WAS UNKNOWN, HOWEVER, THE PATIENT WAS TRANSITIONED TO HEMODIALYSIS AND PASSED AWAY FEW DAYS LATER ON (B)(6) 2018. THE PATIENT WAS NOT DIALYZING NOR WAS CONNECTED TO THE CYCLER AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS STATED TO BE SMALL BOWEL OBSTRUCTION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A PERITONEAL DIALYSIS PATIENT HAD EXPIRED. UPON FURTHER FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT STATED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 FOR BOWEL OBSTRUCTION. THE TREATMENT RENDERED AT THE HOSPITAL WAS UNKNOWN, HOWEVER, THE PATIENT WAS TRANSITIONED TO HEMODIALYSIS AND PASSED AWAY FEW DAYS LATER ON (B)(6) 2018. THE PATIENT WAS NOT DIALYZING NOR WAS CONNECTED TO THE CYCLER AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS STATED TO BE SMALL BOWEL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171430 LIBERTY SELECT CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death