BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CYCLER, FREEDOM 5-LEAD PEDIATRIC CYCLER SET

    MDR report key: 4016921 · Received July 24, 2014

    Report

    Report Number
    8030665-2014-00575
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 14, 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 FAMATA. HIS LAST POSITIVE BACTERIAL CULTURE OF THE PD FLUID WAS ON (B)(6) 2014. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A CALL TO TECHNICAL SERVICE REGARDING AN ALARM ISSUE REGARDING THE CYCLER, IT WAS INDICATED BY THE PATIENT'S MOTHER THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO AN EPISODE OF PERITONITIS. THE CLINICAL MANAGER STATED THE PATIENT WAS PREVIOUSLY ADMITTED TO THE HOSPITAL FOR PERITONITIS, WAS DISCHARGED AND IS CURRENTLY COMPLETING TREATMENTS USING THE NEW CYCLER WITHOUT ISSUE. THE FOLLOWING WAS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S TREATMENT FACILITY. 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 ALSO PREVIOUSLY HOSPITALIZED ON (B)(6) 2014 THROUGH (B)(6) 2014 DUE TO BACTERIAL AND FUNGAL PERITONITIS AND THE CONCERN WITH THIS ADMISSION WAS FOR AN ATYPICAL CANDIDA SPECIES RESISTANT TO FLUCONAZOLE HAD FORMED A BIOFILM WITHIN HIS CATHETER. THE PATIENT HAS HAD INTERMITTENT DIARRHEA AND EMESIS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432949 FREEDOM CYCLER, FREEDOM 5-LEAD PEDIATRIC CYCLER SET KPF FRESENIUS MEDICAL CARE NORTH AMERICA 13BR08880

    Patients

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