BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER

    MDR report key: 7699248 · Received July 18, 2018

    Report

    Report Number
    2937457-2018-02010
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 18, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. FURTHER INVESTIGATION WAS NOT ABLE TO BE PERFORMED. THE SERIAL NUMBER OF THE CYCLER USED WAS UNKNOWN, THEREFORE AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS UNABLE TO BE CONDUCTED BY THE MANUFACTURER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CLINICAL REVIEW: A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT AND THE SYMPTOMS OF NAUSEA, VOMITING, SHORTNESS OF BREATH, AND MIDSTERNAL PAIN. ALTHOUGH THERE IS AN ALLEGATION THE PATIENT EXPERIENCED AN OVERFILL EVENT; IT CANNOT BE CONFIRMED WITH THE INFORMATION AT HAND. CCPD TREATMENT DATA AND THE PATIENT¿S DISCHARGE SUMMARY WERE NOT AVAILABLE. HOWEVER, IIPV IS A KNOWN ADVERSE EVENT THAT CAN OCCUR WITH USE OF THE LIBERTY SELECT CYCLER FOR PD; THEREFORE, A POSSIBLE CAUSAL OR CONTRIBUTORY RELATIONSHIP CANNOT BE EXCLUDED. ALTHOUGH A DIRECT CAUSAL RELATIONSHIP COULD NOT BE CONFIRMED, A TEMPORAL RELATIONSHIP BETWEEN THE PATIENT'S PD TREATMENT AND THE OVERFILL SYMPTOMS REMAINS. SHOULD ADDITIONAL NEW INFORMATION BE MADE AVAILABLE THIS CLINICAL INVESTIGATION WILL BE REEVALUATED.

    Description of Event or Problem · 1

    A PATIENT] ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) EXPERIENCED SYMPTOMS OF AN OVERFILL EVENT, CHARACTERIZED BY NAUSEA, VOMITING, SHORTNESS OF BREATH AND MIDSTERNAL PAIN. CCPD TREATMENT SUMMARY DETAILS INDICATED BLOOD PRESSURE (BP) RANGE 123/179, PULSE(P) 100, TEMPERATURE (T) 97.4 AND A WEIGHT OF (B)(6) KILOGRAMS (KG). SUBSEQUENT VITALS RECORDED BP 154/86, P 83, T 97.2 AND WEIGHT (B)(6) KILOGRAMS. THE PATIENT WAS SUBSEQUENTLY SENT TO THE EMERGENCY ROOM (ER). PER THE PD NURSE, THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED HOME THE SAME DAY. THE PATIENT¿S DISCHARGE SUMMARY AND FURTHER CCPD TREATMENT RECORDS WERE NOT AVAILABLE. PER THE NURSE, THE PATIENT RECOVERED AND CONTINUES PD THERAPY WITHOUT FURTHER REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541576 LIBERTY SELECT CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

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