BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 7970274 · Received October 16, 2018

    Report

    Report Number
    2937457-2018-03087
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 24, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. 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 IDENTIFIED 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.

    Additional Manufacturer Narrative · 1

    CLINICAL REVIEW: A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT AND THE REPORTED SHORTNESS OF BREATH WITH SUBSEQUENT DIAGNOSIS OF HYPOXIC RESPIRATORY FAILURE DUE TO FLUID OVERLOAD AND PULMONARY EDEMA. THERE IS NO DOCUMENTATION TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE LIBERTY SELECT CYCLER. THE PATIENT¿S GI BLEED IS NOT RELATED TO PD THERAPY. THE GI BLEED IS AN ONGOING ISSUE WITH THE PATIENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO DOCUMENTATION OR INDICATION THE LIBERTY SELECT CYCLER CAUSED OR CONTRIBUTED TO A SERIOUS ADVERSE PATIENT EVENT. ADDITIONALLY, THE PATIENT HAS CHRONIC SHORTNESS OF BREATH, EXTENSIVE COMORBIDITIES AND CHRONIC HYPOXIC RESPIRATORY FAILURE WHICH COULD HAVE CONTRIBUTED TO THE EVENT. ALTHOUGH A CAUSAL RELATIONSHIP CANNOT BE CONFIRMED, A TEMPORAL RELATIONSHIP BETWEEN THE PATIENT'S PD THERAPY AND THE REPORTED EVENT REMAINS. SHOULD ADDITIONAL NEW INFORMATION BE MADE AVAILABLE THIS CLINICAL INVESTIGATION WILL BE REEVALUATED. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND TWO EPISODES OF DARK RED BLOOD PER RECTUM. THIS PATIENT HAS A HISTORY OF CHRONIC ANEMIA THOUGHT TO BE DUE TO CHRONIC RENAL DISEASE. THE PATIENT HAS CHRONIC SHORTNESS OF BREATH AND IS ON HOME OXYGEN. THE ADMISSION RESULTED IN A DIAGNOSIS OF ACUTE ON CHRONIC HYPOXIC RESPIRATORY FAILURE RELATED TO FLUID OVERLOAD AND PULMONARY EDEMA AND A LOWER GASTROINTESTINAL BLEED. ETIOLOGY OF THE FLUID OVERLOAD AND PULMONARY EDEMA IS UNKNOWN. THE PATIENT COMPLETED HEMODIALYSIS DURING HOSPITALIZATION WHICH IMPROVED THEIR CONDITION. THE PATIENT ALSO COMPLETED MANUAL EXCHANGES 4 TIMES A DAY UTILIZING 2.5% SOLUTION AND A TOTAL OF 2L PER EXCHANGE. THE PATIENT RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS (PRBC) AND THEIR HEMOGLOBIN (8.8) AND HEMATOCRIT (25.7) VALUES STABILIZED. THE PATIENT UNDERWENT ESOPHAGOGASTRODUODENOSCOPY (EGD) (DATE UNKNOWN) WHICH SHOWED ERYTHEMATOUS MUCOSA IN THE GASTRIC BODY AND ANTRUM, ERYTHEMATOUS DUODENOPATHY AND SOME MUCOSAL CHANGES IN THE ESOPHAGUS SUSPICIOUS FOR EOSINOPHILIC ESOPHAGITIS. A COLONOSCOPY WAS SCHEDULED (DATE UNKNOWN) BUT THE PATIENT¿S BREATHING STATUS WAS COMPROMISED AND REQUIRED TO BE RESCHEDULED. A CHEST X-RAY (DATE UNKNOWN) SHOWED PULMONARY VASCULAR CONGESTION. THE COLONOSCOPY WAS REATTEMPTED (DATE UNKNOWN), HOWEVER, THE PATIENT¿S PREP WAS NOT SUCCESSFUL AND THERE WAS NO VISUALIZATION. THE PATIENT¿S BLEEDING SUBSIDED AND THE PLAN WAS FOR THE PATIENT TO RETURN TO PERITONEAL DIALYSIS UPON DISCHARGE. THE PATIENT WAS DISCHARGED HOME AFTER FIVE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809057 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET | DELFLEX PD FLUID| LIBERTY CYCLER SET