BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 5447555 · Received February 19, 2016

    Report

    Report Number
    2937457-2016-00189
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 23, 2016
    Report Date
    March 14, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THERE WERE NO REPORTED DEVICE MALFUNCTIONS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO DOCUMENTATION IN THE MEDICAL RECORD SUPPORTING A POSSIBLE ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT OF PERITONITIS. HOWEVER, THERE IS A PROBABLE ASSOCIATION BETWEEN BREAKING THE STERILE PATHWAY OF PD THERAPY AND PERITONITIS. MEDICAL RECORDS DID NOT CONTAIN ADDITIONAL LABORATORY RESULTS FOR REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION AND REVIEW OF MEDICAL RECORDS.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS INFORMATION IT APPEARS THIS (B)(6) WHITE FEMALE ESRD PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY BEING CARRIED OUT DAILY THROUGH DELFLEX VIA INTRAPERITONEAL (IP) ROUTE WITH DOSE REGIMEN NOT REPORTED, STARTED RENAL REPLACEMENT THERAPY ON (B)(6) 2014, AND STARTED PD THERAPY ON (B)(6) 2014. ON (B)(6) 2016, THE PATIENT PRESENTED TO A HOSPITAL'S EMERGENCY DEPARTMENT WITH DIFFUSE ABDOMINAL PAIN, NAUSEA, A COUPLE OF EPISODES OF EMESIS WITHOUT HEMATEMESIS AND A SMALL AMOUNT OF DIARRHEA. THE PATIENT'S PD FLUID WAS COLLECTED AND SHOWED GREATER THAN 12,000 WHITE BLOOD CELLS ON STAIN WITHOUT BACTERIA PRESENT. THE PATIENT WAS DIAGNOSED WITH STREPTOCOCCUS VIRIDANS PERITONITIS AND WAS ADMITTED. REVIEW OF MEDICAL RECORDS REVEALED DURING THE ADMISSION HISTORY AND PHYSICAL, IT WAS REPORTED THE PATIENT HAD DIFFICULTY WITH HER PD AT HOME. ON (B)(6) 2016, THE PATIENT WAS ADMINISTERED 2 MILLIGRAMS/KILOGRAMS GENTAMICIN IP ROUTE TO DWELL FOR SIX HOURS AND VANCOMYCIN 1 GRAM IP ROUTE, DOSE REGIMEN NOT REPORTED. THE PATIENT'S PD NURSE STATED THE EPISODE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION, WHERE THE PATIENT DID NOT PRACTICE ASEPTIC TECHNIQUE AND BROKE THE STERILE FIELD DURING TREATMENT. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED HOME AND PRESCRIBED ANCEF (CEFAZOLIN) VIA IP ROUTE FOR 14 DAYS WITH DOSE REGIMEN NOT REPORTED. ON (B)(6) 2016, THE PATIENT PRESENTED TO A HOSPITAL WITH WORSENING GENERALIZED MALAISE WITH CHILLS, AFEBRILE, SOME ABDOMINAL PAIN DURING EXCHANGES, ANOREXIA WITH NAUSEA AND MULTIPLE EPISODES OF VOMITING WITHOUT HEMATEMESIS, WAS DIAGNOSED WITH RECURRENT STREPTOCOCCUS VIRIDANS PERITONITIS AND WAS ADMITTED. ON (B)(6) 2016, PD FLUID COLLECTED SHOWED WHITE BLOOD CELLS 9,347UL, RED BLOOD CELLS 10,915UL, STRAW COLOR, CLOUDY, NEUTROPHILS 92%, LYMPHOCYTES 4%, LARGE MONONUCLEAR CELLS 4%, GRAM STAIN MODERATE WHITE BLOOD CELLS, NO ORGANISMS SEEN. AS OF 02/18/2016, IT IS UNKNOWN IF THE EVENT OF PERITONITIS HAS RESOLVED. IT IS UNKNOWN IF THE PATIENT CONTINUES TO BE HOSPITALIZED AND IT IS UNKNOWN IF THE PATIENT CONTINUES CCPD THERAPY WITHOUT ANY FURTHER ISSUES OR INJURIES.

    Description of Event or Problem · 1

    DURING A CALL TO TECHNICAL SUPPORT, THE PATIENT REPORTED THAT SHE HAD BEEN HOSPITALIZED WITH PERITONITIS. A FOLLOW UP CALL TO THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE DIAGNOSIS. THE PATIENT WAS ADMITTED WITH PERITONITIS ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016. THE NURSE ALSO STATED THE PATIENT IS ELDERLY WITH NUMEROUS COMORBIDITIES. THE PATIENT ALSO HAS MULTIPLE CATS WHO LIVE WITH HER. THE LIKELY CAUSE OF THE PERITONITIS WAS DUE TO TOUCH CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103890 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R