BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 6672534 · Received June 28, 2017

    Report

    Report Number
    2937457-2017-00517
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    June 15, 2017
    Report Date
    July 24, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. THE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A SERIAL NUMBER SEARCH FOUND NO COMPLAINT ISSUES WITH THE SAME SYMPTOM CODE WITHIN 90 DAYS OF THE NOTIFIED DATE. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A PROBABLE TEMPORAL RELATIONSHIP EXISTS BETWEEN PD THERAPY (WITH FRESENIUS PRODUCTS) AND PT. EXPERIENCING ABDOMINAL PAIN/NAUSEA/VOMITING/WEIGHT LOSS (OVER A PERIOD OF TWO WEEKS) WITH SUBSEQUENT HOSPITALIZATION FOR FLUID VOLUME OVERLOAD WITH ELECTROLYTE IMBALANCE (NA, K, MG). HOWEVER, THE PATIENT ALSO HAS KNOWN PRE-EXISTING HYPONATREMIA WITH SEIZURE ACTIVITY (UNKNOWN DATE) AND HYPOMAGNESEMIA WHICH THE PATIENT IS MEDICALLY TREATED WITH MG SUPPLEMENTS AT HOME. THE PATIENT REPORTEDLY HAD DECREASED ORAL INTAKE AND WAS MEDICALLY TREATED WITH LASIX (A DIURETIC) WHICH MAY BE A FACTOR IN THE PATIENT DEVELOPMENT OF HYPOKALEMIA, ALTHOUGH THE PATIENT HAD AN ADMISSION K OF 4.0. FURTHERMORE, THE PATIENT HAS A HISTORY OF GERD WHICH CAN BE CONTRIBUTORY TO ABDOMINAL PAIN, NAUSEA AND VOMITING. THEREFORE, ACTUAL CAUSALITY FOR ADVERSE EVENTS CANNOT BE DETERMINED DUE TO MULTIFACTORIAL POSSIBLE CONTRIBUTORS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S CONTACT REPORTED ON (B)(6) 2017 THE PATIENT WAS IN THE HOSPITAL. FOLLOW-UP REVEALED THE PATIENT CONTACT HAD BROUGHT THE PD PATIENT TO THE HOSPITAL TO HAVE HER MEDICATION ADJUSTED, AS IT HAD BEEN CAUSING HER TO GAIN FLUID WEIGHT AND SHE WAS FLUID OVERLOADED. (B)(6) STATED HIS WIFE WAS HOSPITALIZED FROM (B)(6) 2017 DUE TO FLUID OVERLOAD. THE PATIENT RECEIVED ADEQUATE PERITONEAL DIALYSIS THERAPY WHILE HOSPITALIZED. MEDICAL RECORDS WERE REQUESTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S CONTACT REPORTED ON (B)(6) 2017 THE PATIENT WAS IN THE HOSPITAL. FOLLOW-UP REVEALED THE PATIENT CONTACT HAD BROUGHT THE PD PATIENT TO THE HOSPITAL TO HAVE HER MEDICATION ADJUSTED, AS IT HAD BEEN CAUSING HER TO GAIN FLUID WEIGHT AND SHE WAS FLUID OVERLOADED. THOMAS STATED HIS WIFE WAS HOSPITALIZED FROM (B)(6) 2017 DUE TO FLUID OVERLOAD. THE PATIENT RECEIVED ADEQUATE PERITONEAL DIALYSIS THERAPY WHILE HOSPITALIZED. MEDICAL RECORDS WERE REQUESTED.

    Description of Event or Problem · 1

    INFORMATION IN THE COMPLAINT FILE AND MEDICAL RECORDS WERE REVIEWED BY A POST MARKET SURVEILLANCE CLINICIAN. ON (B)(6) 2017 IT WAS REPORTED THIS PERITONEAL DIALYSIS (PD) PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) THERAPY REPORTED BEING HOSPITALIZED (UNKNOWN ADMISSION DATE/UNKNOWN REASON). THE PATIENT¿S HUSBAND STATED THE PATIENT HAD BEEN ABLE TO COMPLETE CCPD TREATMENTS ON THE CYCLER. ON 06/27/2017 DURING A FOLLOW UP CALL WITH THE PATIENT¿S HUSBAND IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL ON (B)(6) 2017 BECAUSE THE PATIENT WAS EXPERIENCING FLUID GAINS AND WAS FLUID VOLUME OVERLOADED (SIGNS AND SYMPTOMS UNKNOWN). THE PT¿S HUSBAND REPORTED THE PT. DID NOT EXPERIENCE ANY PROBLEMS WITH OVERFILL OR INJURY AS A RESULT OF CCPD THERAPY AND STATED THE PATIENT HAD HER ¿MEDICATION ADJUSTED¿ (UNKNOWN MEDICATION) IN THE HOSPITAL. IT WAS REPORTED THE PATIENT RECEIVED PD TREATMENTS WHILE HOSPITALIZED AND WAS DISCHARGED ON (B)(6) 2017. REVIEW OF THE MEDICAL RECORDS REVEALED ON (B)(6) 2017 THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) EXPERIENCING NAUSEA AND INTERMITTED VOMITING WITH DECREASED ORAL INTAKE FOR APPROXIMATELY 2 WEEKS, RESULTING LOSS OF 7 POUNDS (LBS.) SINCE THE SYMPTOMS BEGAN. THE PATIENT ALSO REPORTED HAVING INTERMITTENT ABDOMINAL AND EPIGASTRIC BURNING/PAIN. THE PATIENT WAS EVALUATED BY GASTROENTEROLOGY AND NEPHROLOGY SERVICES. A 10 POINT REVIEW OF SYSTEMS WAS PERFORMED AND NOTABLY NEGATIVE EXCEPT FOR THE PT¿S PRESENTING SYMPTOMS. HOWEVER, THE PATIENT DID HAVE BILATERAL (BL) LOWER EXTREMITY (LE) 1+PITTING EDEMA AND WAS REPORTEDLY SLIGHTLY FLUID OVERLOADED ON PRESENTATION (CONCOMITANT SYMPTOMS UNKNOWN). THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR MEDICAL EVALUATION AND MANAGEMENT UNDER THE IMPRESSION THE PATIENT SYMPTOMS MAY HAVE BEEN RELATED TO HER PEPTIC ULCER DISEASE OR MILD UREMIA/FLUID VOLUME OVERLOAD DUE TO INSUFFICIENT PD THERAPY. REPORTEDLY, THE PATIENT UNDERWENT ¿INTENSIFIED¿ PD (UNKNOWN PRODUCTS/ TREATMENT DETAILS/DIALYSIS PRESCRIPTION) AND THE PATIENT SYMPTOMS/HYPONATREMIA IMPROVED. DURING HOSPITALIZATION THE PATIENT UNDERWENT AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2017, WHICH REVEALED NON-SPECIFIC ABDOMINAL ASCITES, NO DEFINITE INFLAMMATORY PROCESS IN THE ABDOMEN/PELVIS AND EXTENSIVE SIGMOID DIVERTICULOSIS. IT WAS SUBSEQUENTLY DISCOVERED THE PATIENT WAS MILDLY HYPOKALEMIC AND THEREFORE RECEIVED K REPLACEMENT THERAPY. REPEAT K; 4.1. THE PATIENT RECEIVED MAGNESIUM (MG) REPLACEMENT HYPOMAGNESEMIA. THE PATIENT¿S HYPONATREMIA WAS NOTABLY IMPROVED THROUGH FLUID MANAGEMENT WITH INTENSIFIED HOSPITAL PD TREATMENTS AND NA WAS NOTED TO BE 130 AT THE TIME OF HOSPITAL DISCHARGE. MOREOVER, THE PT. WAS NOTED TO HAVE SLIGHTLY ELEVATED ASPARTATE AMINOTRANSFERASE AND AN ABDOMINAL ULTRASOUND WAS PERFORMED. IT WAS NOTED THE AST WAS 49/ALT WAS 59 ON THE DAY OF DISCHARGE OF (B)(6) 2017. THEREFORE LIVER FUNCTION TESTS REMAINED STABLE DURING HOSPITALIZATION. TREATMENT FOR ANEMIA WAS UNKNOWN. ON (B)(6) 2017, IT WAS NOTED THE PATIENT SYMPTOMS OF NAUSEA AND VOMITING HAD RESOLVED. THE PATIENT¿S HUSBAND WAS PROVIDED EDUCATION OF FLUID RESTRICTION AND IT WAS DISCUSSED THE PATIENT WOULD CONTINUE MAGNESIUM SUPPLEMENT AT HOME. THE PATIENT WAS DISCHARGED HOME WITH A PLAN TO FOLLOW-UP IN OUTPATIENT PD CLINIC AND GASTROENTEROLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455759 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R LIBERTY CYCLER CASSETTE| PD SOLUTION