BEUDAMED
    FDA Adverse Event Death Summary report: N

    UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)

    MDR report key: 6997104 · Received November 2, 2017

    Report

    Report Number
    2937457-2017-01128
    Event Type
    Death
    Date Received
    November 2, 2017
    Date of Event
    October 4, 2017
    Report Date
    November 13, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE DETERMINED IF THERE IS A CASUAL RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE LIBERTY CYCLER AS IT IS UNKNOWN IF THE PATIENT WAS ACTIVELY COMPLETING PERITONEAL DIALYSIS (PD) TREATMENT AT THE TIME OF DEATH. THE CAUSE OF DEATH IS UNKNOWN. ADDITIONALLY, THERE ARE NO ALLEGATIONS OF A MALFUNCTION AGAINST THE LIBERTY CYCLER. IT IS UNKNOWN IF THE PATIENT HAD PRE-EXISTING COMORBIDITIES OR CONCOMITANT MEDICATIONS THAT CONTRIBUTED TO THE PATIENT¿S DEATH. AT THIS TIME, NO CONCLUSION CAN BE MADE IF THERE WAS OR WAS NOT A CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND THE LIBERTY CYCLER. PLANT INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS INVESTIGATION. 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 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 · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT THE CYCLER ALARMED FOR BLOCKED SUPPLY BAG LINES DURING DWELL 4 OF 4 ON (B)(6) 2017. THE PATIENT HAD A BAXTER BAG CONNECTED TO THE GREEN CLAMP LINE AND THE LAST BAG OPTION WAS SET TO ¿YES,¿ HOWEVER, THE BAG WAS EMPTY. THE PATIENT STATED THAT HIS HOUSE HAD LOST POWER BUT WAS ABLE TO RESUME TREATMENT. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM THE PATIENT¿S SON WHO REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2017. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776090 UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LIBERTY CYCLER SET| PERITONEAL DIALYSIS (PD) FLUID