BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 7473954 · Received April 30, 2018

    Report

    Report Number
    2937457-2018-01190
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 8, 2018
    Report Date
    May 4, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FOR SHORTNESS OF BREATH (SOB), FLUID OVERLOAD, FATIGUE, PNEUMONIA (PNA), TACHYCARDIA, MILD CONFUSION AND FEVER. DURING THE HOSPITALIZATION THE PATIENT¿S SOB WAS TREATED WITH A ¿VAPOTHERM¿, AND UNDERWENT A CHEST X-RAY AND COMPUTED TOPOGRAPHY (CT) SCAN WHICH, SUBSEQUENTLY LEAD TO THE PATIENT BEING DIAGNOSED WITH PNEUMONIA (PNA). THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ROCEPHIN, AND AZITHROMYCIN (DOSAGE, DURATION AND FREQUENCY UNKNOWN) WHICH ASSISTED IN IMPROVING THE PATIENT¿S FEVER, TACHYCARDIA, SOB, CONFUSION AND FATIGUE. GIVEN THE PATIENT¿S DIAGNOSIS OF PNA AND A KNOWN HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), THE PATIENT WAS ALSO GIVEN IV PREDNISONE (DOSAGE AND FREQUENCY UNKNOWN). IT IS UNKNOWN WHAT FORM OF RENAL REPLACEMENT THERAPY (RRT) WAS PERFORMED DURING THE HOSPITALIZATION, OR IF ANY FRESENIUS DEVICE(S) OR PRODUCTS WERE UTILIZED. THE SHORTNESS OF BREATH (SOB), MILD CONFUSION, FEVER, FATIGUE AND TACHYCARDIA WERE ATTRIBUTED TO THE PNEUMONIA (PNA) (COMMUNITY ACQUIRED) AND COPD EXACERBATION, DUE TO FLUID OVERLOAD. THE PATIENT WAS REPORTED TO BE RECOVERING AND CONTINUING PERITONEAL DIALYSIS THERAPY. CLINICAL INVESTIGATION: A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE PERITONEAL DIALYSIS (PD) TREATMENT AND THE ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION THERE IS A POSSIBLE TEMPORAL RELATIONSHIP BETWEEN CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) TREATMENTS WITH THE LIBERTY SELECT CYCLER AND THE PATIENT EVENT(S) WHICH REQUIRED INPATIENT HOSPITALIZATION. THE ETIOLOGY FOR THE PATIENT¿S PNEUMONIA IS ¿COMMUNITY ACQUIRED.¿ THERE IS NO REPORTED ALLEGATION OR OBJECTIVE EVIDENCE THAT INDICATES A LIBERTY SELECT CYCLER MALFUNCTION THAT MAY HAVE BEEN A POSSIBLE CAUSAL FACTOR IN THE PATIENT¿S PNEUMONIA.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED ON THE CYCLER WITH NO PHYSICAL DAMAGE NOTED. THERE WERE NO VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED ON THE CYCLER WITH NO ISSUES NOTED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT¿S CONTACT REQUESTED A REPLACEMENT CYCLER DUE TO ALARMS (UNKNOWN) DURING TREATMENT (TX) (PHASE AND CYCLE UNKNOWN). UPON FURTHER FOLLOW UP THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 DUE TO PNEUMONIA AND WAS DISCHARGED ON (B)(6) 2018. THE CAUSE OF THE PNEUMONIA WAS UNKNOWN. THE PDRN STATED THAT DURING THE HOSPITALIZATION PATIENT¿S TARGET WEIGHT WAS CHANGED DUE TO FLUID OVERLOAD. THE PATIENT WAS REPORTED TO BE RECOVERING AND CONTINUING CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) ON THE CYCLER WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314593 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET