BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 6800221 · Received August 17, 2017

    Report

    Report Number
    2937457-2017-00739
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 30, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THERE IS NO DOCUMENTATION THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE HOSPITALIZATION FOR THE GI BLEED AND THE LIBERTY CYCLER OR ANY FRESENIUS PRODUCT. ADDITIONALLY, THERE IS NO ALLEGATION OF DEFICIENCY AGAINST ANY FRESENIUS PRODUCT. AT THIS TIME WITHOUT ADDITIONAL INFORMATION NO CONCLUSION CAN BE MADE THAT THERE WAS ANY CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S GI BLEED ISSUE AND HOSPITALIZATION AND THE LIBERTY CYCLER. HOWEVER, A POSSIBLE ASSOCIATION OF BEING A DIALYSIS PATIENT AND THE DEVELOPMENT OF GI BLEEDING DOES EXIST. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT DEFAULTED TO THE BEGINNING OF THE MONTH AS THE ACTUAL EVENT DATE IS UNKNOWN AT THIS TIME. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    RMATION IN THE COMPLAINT FILE WAS REVIEWED. DURING A FOLLOW UP PHONE CALL ON 08/11/2017 TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), FOR AN UNRELATED ISSUE, IT WAS DISCOVERED THAT THIS MALE PATIENT WAS HOSPITALIZED IN (B)(6) 2017 (NO KNOWN DATE). ACCORDING TO THE PDRN, THE PATIENT WAS HOSPITALIZED FOR A HEALTH CONDITION UNRELATED TO THE CONTINUOUS CYCLE PERITONEAL DIALYSIS (CCPD) THERAPY, WHICH WAS A GASTROINTESTINAL (GI) BLEED. ADDITIONAL INFORMATION RELATED TO THE HOSPITALIZATION IS WAS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S CLINIC REGISTERED NURSE (RN) REPORTED THE PDPATIENT WAS HOSPITALIZED IN (B)(6) 2017 (NO SPECIFIC DATE WAS PROVIDED) FOR GASTROINTESTINAL (GI) BLEEDING. ADDITIONAL INFORMATION AND MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581892 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

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