BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 6167096 · Received December 12, 2016

    Report

    Report Number
    2937457-2016-01218
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    August 31, 2016
    Report Date
    January 4, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION AGAINST FRESENIUS PRODUCTS. THE E COLI PERITONITIS IS UNLIKELY CAUSED BY FRESENIUS PERITONEAL DIALYSIS PRODUCTS AND LIKELY DUE TO BOWEL HYGIENE ISSUES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE PLANT'S INVESTIGATION.

    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. IN ADDITION, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP WITH THE PERITONEAL DIALYSIS (PD) PATIENT¿S NURSE, IT WAS REPORTED THAT THE PATIENT HAD BEEN IN GENERAL HEALTH DECLINE SINCE THEIR ADMISSION ON (B)(6) 2016 FOR ESCHERICHIA COLI PERITONITIS. THE NURSE REPORTED THAT THIS WAS DUE TO BOWEL TRANSLOCATION OF BACTERIA. THE PATIENT RECEIVED TREATMENT WITH ANTIBIOTICS (SPECIFIC ANTIBIOTICS UNKNOWN) VIA AN INTRA-PERITONEAL ROUTE (IP) WITH THE LAST DOSE ON (B)(6) 2016. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2016, WHERE THEY CONTINUED PD DURING THIS TIME. ON (B)(6) 2016, THE PATIENT WAS READMITTED FOR REPEAT PERITONITIS AND WAS TREATED AGAIN WITH ANTIBIOTICS, AND A RECOMMENDATION THAT THE PD CATHETER BE REMOVED. THE PATIENT AND THEIR FAMILY REFUSED. THE PATIENT WAS BECOMING VERY WEAK, WAS NOT EATING, AND DECIDED TO RETURN HOME; THE PATIENT¿S WIFE WAS CONSEQUENTLY TRAINED ON ADMINISTERING ANTI-BIOTICS VIA AN IP ROUTE. AT HOME THE PATIENT CONTINUED TO GET WEAKER, AND BECAME ANOREXIC. THE PATIENT HAD A COUPLE OF DAYS HISTORY OF NAUSEA AND VOMITING, AND DURING A HOME VISIT ON (B)(6) 2016, THE NURSE TRIED TO GET A PRESCRIPTION FOR ZOFRAN. DURING THE NURSE'S VISIT, THEY FOUND THE PATIENT'S SATURATED O2 LEVEL WAS 76% ON ROOM AIR. THE NURSE FELT THAT THE PATIENT COULD HAVE ASPIRATED, AND MIGHT ALSO HAVE SOME ASPIRATION PNEUMONIA, AND CALLED EMERGENCY SERVICES. WHEN THE PATIENT ARRIVED AT THE HOSPITAL, THEY WERE IN FULL CARDIAC ARREST. THE PATIENT DIED THE FOLLOWING DAY, (B)(6) 2016, DUE TO UNKNOWN CAUSES.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP WITH THE PERITONEAL DIALYSIS (PD) PATIENT¿S NURSE, IT WAS REPORTED THAT THE PATIENT HAD BEEN IN GENERAL HEALTH DECLINE SINCE THEIR ADMISSION ON (B)(6) 2016 FOR ESCHERICHIA COLI PERITONITIS. THE NURSE REPORTED THAT THIS WAS DUE TO BOWEL TRANSLOCATION OF BACTERIA. THE PATIENT RECEIVED TREATMENT WITH ANTIBIOTICS (SPECIFIC ANTIBIOTICS UNKNOWN) VIA AN INTRA-PERITONEAL ROUTE (IP) WITH THE LAST DOSE ON (B)(6) 2016. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2016, WHERE THEY CONTINUED PD DURING THIS TIME. ON (B)(6) 2016, THE PATIENT WAS READMITTED FOR REPEAT PERITONITIS AND WAS TREATED AGAIN WITH ANTIBIOTICS, AND A RECOMMENDATION THAT THE PD CATHETER BE REMOVED. THE PATIENT AND THEIR FAMILY REFUSED. THE PATIENT WAS BECOMING VERY WEAK, WAS NOT EATING, AND DECIDED TO RETURN HOME; THE PATIENT¿S WIFE WAS CONSEQUENTLY TRAINED ON ADMINISTERING ANTI-BIOTICS VIA AN IP ROUTE. AT HOME THE PATIENT CONTINUED TO GET WEAKER, AND BECAME ANOREXIC. THE PATIENT HAD A COUPLE OF DAYS HISTORY OF NAUSEA AND VOMITING, AND DURING A HOME VISIT ON (B)(6) 2016, THE NURSE TRIED TO GET A PRESCRIPTION FOR ZOFRAN. DURING THE NURSE'S VISIT, THEY FOUND THE PATIENT'S SATURATED O2 LEVEL WAS 76% ON ROOM AIR. THE NURSE FELT THAT THE PATIENT COULD HAVE ASPIRATED, AND MIGHT ALSO HAVE SOME ASPIRATION PNEUMONIA, AND CALLED EMERGENCY SERVICES. WHEN THE PATIENT ARRIVED AT THE HOSPITAL, THEY WERE IN FULL CARDIAC ARREST. THE PATIENT DIED THE FOLLOWING DAY, (B)(6) 2016, DUE TO UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818193 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| R LIBERTY CYCLER CASSETTE| PD FLUID