BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY DIALYSIS CYCLER

    MDR report key: 3980018 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01602
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE POST MARKET CLINICAL STAFF REVIEWED THE PROVIDED MEDICAL RECORDS INFORMATION AND IT APPEARS THAT ON (B)(6) 2014, A SERIOUS INJURY OF PERITONITIS IS BEING REPORTED. ON (B)(6) 2014, THE PATIENT WENT TO THE PD CLINIC COMPLAINING OF LACK OF DRAINAGE THROUGH HER PD CATHETER AND RIGHT LOWER QUADRANT ABDOMINAL PAIN. SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, SHE WAS SEEN BY INTERVENTIONAL RADIOLOGY WHICH CONFIRMED THAT HER PD CATHETER WAS COMPLETELY BLOCKED. ON (B)(6) 2014, HER PD CATHETER WAS REMOVED AND A NEW CATHETER WAS NOT INSERTED DUE TO CLOUDY PD FLUID. SHE WAS STARTED ON HEMODIALYSIS 3 TIMES A WEEK. THE PATIENT WAS DIAGNOSED WITH (B)(6) PERITONITIS IN (B)(6) 2014. DURING THE CURRENT ADMISSION (B)(6) WAS ISOLATED IN HER EFFLUENT PD FLUID. PERITONITIS IS A KNOWN COMPLICATION OF PD THERAPY AND IS MOST LIKELY CAUSED BY A BREACH IN ASEPTIC TECHNIQUE DURING TREATMENT. IT IS UNLIKELY THAT THE PATIENT'S EVENT OF PERITONITIS IS RELATED TO THE ABOVE MENTIONED FRESENIUS PRODUCTS. THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED DURING DRAIN 1, PATIENT WAS NOT DRAINING AND AN ALARM WENT OFF. THE PATIENT, PIN WERE OPEN, CLAMPS WERE OPEN, AND THERE WERE NO APPARENT KINKS OR OBSTRUCTIONS. PATIENT DRAINS TO TUB, DRAIN CAP WAS REMOVED, NO APPARENT AIR IN THE PATIENT LINE BUT SLIGHT AIR BUBBLE IN THE DRAIN LINE (DL). PATIENT RESET TO RESUME TREATMENT, BUT STATED, HE COULD SEE SEVERAL AIR GAPS IN THE DL AT THIS TIME. PATIENT IS TREATMENT BASED, PATIENT WAS UNABLE TO CONTINUE TREATMENT DUE TO AIR IN THE LINE, ADVISED TO CONTACT CLINIC REGARDING TREATMENT. ON (B)(6) 2014, THE PATIENT WENT TO THE PERITONEAL (PD) CLINIC COMPLAINING OF LACK OF DRAINAGE THROUGH HER PD CATHETER. ANALYSIS OF THE EFFLUENT PD FLUID SHOWED 250 WHITE CELLS, AND MOST OF THEM WERE POLYMORPH CELLS. THE PATIENT ALSO COMPLAINED OF RIGHT LOWER QUADRANT ABDOMINAL PAIN AND WAS ADVISED TO GO TO THE EMERGENCY ROOM (ER). WHILE IN THE E.R., CULTURES WERE TAKEN OF THE PATIENT'S EFFLUENT PD FLUID. SHE WAS GIVEN ONE GRAM OF VANCOMYCIN AND 80 MG OF GENTAMYCIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, SHE WAS SEEN BY INTERVENTIONAL RADIOLOGY WHICH CONFIRMED HER PD CATHETER WAS COMPLETELY BLOCKED. ON (B)(6) 2014, HER PD CATHETER WAS REMOVED AND A NEW CATHETER WAS NOT INSERTED DUE TO CLOUDY PD FLUID. THE PATIENT UNDERWENT INTERMITTENT HEMODIALYSIS THROUGH HER RIGHT UPPER ARM ARTERIAL-VENOUS FISTULA. SHE WAS SCHEDULED FOR HEMODIALYSIS 3 TIMES A WEEK. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. SHE WAS TO CONTINUE WITH VANCOMYCIN 1 GM INTRAVENOUSLY NEXT THURSDAY AND THE FOLLOWING TUESDAY. SHE WAS TO CONTINUE WITH GENTAMYCIN 60 MG INTRAVENOUS EVERY DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370951 LIBERTY DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R PD SOLUTIONS| LIBERTY DIALYSIS TUBING