BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY, CNTRL UNIT, FREEDOM CYCLER (REFURB)

    MDR report key: 4016907 · Received July 24, 2014

    Report

    Report Number
    2937457-2014-01840
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPF
    PMA / PMN Number
    K791584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 THROUGH (B)(6) 2014 AFTER HIS MOTHER REPORTED A ONE DAY HISTORY OF CLOUDY, PURULENT EFFLUENT PERITONEAL DIALYSIS (PD) FLUID. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 THROUGH (B)(6) 2014 DUE TO BACTERIAL AND FUNGAL PERITONITIS. DURING THIS TIME, HE COMPLETED A 14 DAY COURSE OF CEFEPIME AND FLUCONAZOLE INTRA-PERITONEALLY (IP) THROUGH HIS DIALYSATE. ON (B)(6) 2014 HIS EFFLUENT PD FLUID CULTURES WERE POSITIVE FOR ENTEROBACTER CLOACAE AND KLEBSIELLA PNEUMONIAE. ON (B)(6) 2014 AND (B)(6) 2014, PD FLUID CULTURES WERE POSITIVE. THE FOLLOWING WAS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S TREATMENT FACILITY. HE COMPLETED A 14 DAY COURSE OF CEFEPIME AND FLUCONAZOLE INTRAPERITONEALLY (IP). THE PATIENT HAS A HISTORY OF EMESIS WHICH HAS WORSENED RECENTLY AS WELL AS BASELINE LOOSE AND FREQUENT STOOLS. THE PATIENT WAS NEGATIVE FOR FEVER AND CHILLS. THE PATIENT'S ABDOMEN WAS NON-TENDER WITH NO REBOUND TENDERNESS OR GUARDING. THERE WERE NORMAL BOWEL SOUNDS. HIS GASTROSTOMY TUBE SITE WAS CLEAN AND DRY AND HIS PD CATHETER SHOWED NO SIGNS OF INFLAMMATION. THE PATIENT RECEIVED HIS LAST DOSE OF FLUCONAZOLE IN HIS PD FLUID ON (B)(6) 2014 AND DID NOT START HIS FLUCONAZOLE VIA HIS GASTROSTOMY TUBE UNTIL (B)(6) 2014. THE PATIENT'S LAST POSITIVE FUNGAL CULTURE IN THE PD FLUID WAS ON (B)(6) 2014 GROWING CANDIDA FUMATA. HIS LAST POSITIVE BACTERIAL CULTURE OF THE PD FLUID WAS ON (B)(6) 2014. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    THE DIALYSIS-DEPENDENT PEDIATRIC PATIENT WITH A HISTORY OF ESRD WAS SCHEDULED FOR A NEW RIGHT-SIDED TENCKCOFF HEMO-DIALYSIS CATHETER TO BE INSERTED ON (B)(6) 2014 DUE TO PREVIOUS FUNGAL INFECTION. THE PATIENT UNDERWENT LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER PLACEMENT WITHOUT COMPLICATION. THE PATIENT COMPLETED HEMODIALYSIS TREATMENT THE FOLLOWING MORNING, DURING WHICH A LEFT INGUINAL HERNIA WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434968 ASSY, CNTRL UNIT, FREEDOM CYCLER (REFURB) KPF FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Hospitalization| R KAYEXALATE| AMOXICILLIN| SOMATROPIN| OMEPRAZOLE| FLUCONAZOLE| EPOGEN| VITAMIN D| ONDANSETRON| LANSOPRAZOLE| FERROUS SULFATE| SODIUM CHLORIDE| AMLODIPINE| PD SOLUTIONS| FREEDOM CYCLER CASSETTE