BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)

    MDR report key: 7684873 · Received July 13, 2018

    Report

    Report Number
    2937457-2018-01954
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 25, 2018
    Report Date
    October 22, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A TECHNICAL SERVICES CALL THAT A PERITONEAL DIALYSIS PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE CONFIRMED THE PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. THE NURSE STATED THE PATIENT WAS NON-COMPLIANT AND HAD CHOSEN NOT TO PERFORM TREATMENT FOR THREE DAYS. THE NURSE STATED THE LIBERTY CYCLER WAS NOT MALFUNCTIONING, THE PATIENT CHOSE TO SKIP THE TREATMENTS.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL CONCLUSION: BASED ON REVIEW OF THE INFORMATION AVAILABLE, THERE IS NO DOCUMENTATION OR INDICATION THAT THE LIBERTY CYCLER CAUSED OR CONTRIBUTED TO THE PATIENT¿S GI BLEEDING. THE PATIENT REPORTEDLY REFUSED TO PERFORM PD TREATMENT FOR 3 DAYS WHICH WAS LIKELY ASSOCIATED WITH THE PATIENT¿S ADVERSE EVENT AS UREMIC TOXINS ARE KNOWN CONTRIBUTORY RISK FACTORS FOR GI BLEED IN DIALYSIS PATIENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TECHNICAL SERVICES CALL THAT A PERITONEAL DIALYSIS PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE CONFIRMED THE PATIENT WAS HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. THE NURSE STATED THE PATIENT WAS NON-COMPLIANT AND HAD CHOSEN NOT TO PERFORM TREATMENT FOR THREE DAYS. THE NURSE STATED THE LIBERTY CYCLER WAS NOT MALFUNCTIONING, THE PATIENT CHOSE TO SKIP THE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529106 UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING LIBERTY CYCLER 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DELFLEX PD SOLUTION| LIBERTY CYCLER SET| DELFLEX PD SOLUTION| LIBERTY CYCLER SET