BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 6852797 · Received September 8, 2017

    Report

    Report Number
    8030665-2017-00666
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    June 19, 2017
    Report Date
    January 31, 2018
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKC
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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-CONFORMANCES 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

    CLINICAL EVALUATION: THERE IS NO DOCUMENTATION THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE EVENT OF PERITONITIS AND THE LIBERTY CYCLER. ADDITIONALLY, THERE IS NO ALLEGATION AGAINST ANY FRESENIUS PRODUCTS AND THE EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CYCLER DISPLAYED A DRAIN COMPLICATION AND WAS UNABLE TO BYPASS. THE PATIENT SET UP WITH NEW SUPPLIES. DURING A FOLLOW UP PHONE CALL TO THE PATIENT'S NURSE, IT WAS REPORTED THAT THE PATIENT GOT PERITONITIS ON (B)(6) 2017 AND WAS GIVEN A 14DAY TRAETMENT OF FORTAZ IN HIS SOLUTION. THE CULTURE WAS TAKEN AND THE RESULTS SHOWED (ACINEBACTER BAUMANNI). THE PATIENT WAS ABLE TO COMPLETE TREATMENT THE TIME OF THE CALL AFTER CONTACTING THE RN. SHE ASSISTED THE PATIENT WITH COMPLETING WITH MEDICATED SOLUTION WITHOUT FURTHER ISSUES. THE PATIENT IS STILL RECOVERING.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CYCLER DISPLAYED A DRAIN COMPLICATION AND WAS UNABLE TO BYPASS. THE PATIENT SET UP WITH NEW SUPPLIES. DURING A FOLLOW UP PHONE CALL TO THE PATIENT'S NURSE, IT WAS REPORTED THAT THE PATIENT GOT PERITONITIS ON (B)(6) 2017 AND WAS GIVEN A 14DAY TRAETMENT OF FORTAZ IN HIS SOLUTION. THE CULTURE WAS TAKEN AND THE RESULTS SHOWED (ACINEBACTER BAUMANNI). THE PATIENT WAS ABLE TO COMPLETE TREATMENT THE TIME OF THE CALL AFTER CONTACTING THE RN. SHE ASSISTED THE PATIENT WITH COMPLETING WITH MEDICATED SOLUTION WITHOUT FURTHER ISSUES. THE PATIENT IS STILL RECOVERING.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CYCLER DISPLAYED A DRAIN COMPLICATION AND WAS UNABLE TO BYPASS. THE PATIENT SET UP WITH NEW SUPPLIES. DURING A FOLLOW UP PHONE CALL TO THE PATIENT'S NURSE, IT WAS REPORTED THAT THE PATIENT GOT PERITONITIS ON (B)(6) 2017 AND WAS GIVEN A 14 DAY TREATMENT OF FORTAZ IN HIS SOLUTION. THE CULTURE WAS TAKEN AND THE RESULTS SHOWED (ACINETOBACTER BAUMANNII). THE PATIENT WAS ABLE TO COMPLETE TREATMENT THE TIME OF THE CALL AFTER CONTACTING THE RN. SHE ASSISTED THE PATIENT WITH COMPLETING WITH MEDICATED SOLUTION WITHOUT FURTHER ISSUES. THE PATIENT IS STILL RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631712 LIBERTY CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKC ERIKA DE REYNOSA, S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention LIBERTY CYCLER| PD FLUID