BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY SELECT CYCLER

    MDR report key: 7704461 · Received July 19, 2018

    Report

    Report Number
    2937457-2018-02042
    Event Type
    Death
    Date Received
    July 19, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 19, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. CLINICAL REVIEW: A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT AND THE PATIENT DEATH. THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE LIBERTY SELECT CYCLER. ADDITIONALLY, THERE ARE NO ALLEGATIONS OF A MACHINE MALFUNCTION OR DEFICIENCY AGAINST THE LIBERTY SELECT CYCLER RELATED TO THIS EVENT. IT IS UNKNOWN IF THE PATIENT HAD COMORBIDITIES OR CONCOMITANT MEDICATIONS THAT COULD HAVE CAUSED/CONTRIBUTED TO THE PATIENT DEATH. BASED ON AVAILABLE INFORMATION THE CAUSE OF THE PATIENT DEATH CANNOT BE CONFIRMED. ALTHOUGH A DIRECT CAUSAL RELATIONSHIP COULD NOT BE CONFIRMED, A TEMPORAL RELATIONSHIP BETWEEN THE PATIENT'S PD TREATMENT AND DEATH REMAINS AS THE PATIENT WAS IN ACTIVE TREATMENT AT THE TIME OF DEATH. SHOULD ADDITIONAL NEW INFORMATION BE MADE AVAILABLE THIS CLINICAL INVESTIGATION WILL BE REEVALUATED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT A PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED DURING PD THERAPY ON THE LIBERTY SELECT CYCLER. NO INFORMATION WAS AVAILABLE REGARDING PATIENT TREATMENT. THE PATIENT WAS IN A NURSING HOME AT THE TIME OF DEATH, BUT CAUSE OF DEATH HAS BEEN LISTED AS UNKNOWN. PDRN STATED THAT THE MACHINE WAS CHECKED AND THERE WERE NO ALARMS OR MALFUNCTIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543645 LIBERTY SELECT CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death DELFLEX PD FLUID| LIBERTY CYCLER SET