BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 3811815 · Received March 10, 2014

    Report

    Report Number
    2937457-2014-00357
    Event Type
    Death
    Date Received
    March 10, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 11, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH A FACILITY MDR. THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW: THE USER FACILITY DID NOT REQUEST AN INVESTIGATION BY THE MANUFACTURER'S REGIONAL EQUIPMENT SPECIALIST. THE CYCLER WAS NOT REPLACED AT THE USER FACILITY FOR THE REPORTED CLINICAL SYMPTOMS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE BEEN MANUFACTURED TO SPECIFICATIONS. THE SYSTEM LEVEL REVIEW OF THE LIBERTY CYCLER AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED IN ANY WAY TO THE PATIENT EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE PROVIDED AND HAVE BEEN REVIEWED BY A POST MARKET CLINICIAN STAFF AND PHYSICIAN PATIENT IS A (B)(6) MALE WITH ESRD THAT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF SCROTAL AND SACRAL WOUND, PLACED ON PERITONEAL DIALYSIS USING THE CYCLER AND DELFLEX SOLUTIONS, DEVELOPED FUNGAL PERITONITIS. FUNGAL PERITONITIS (FP) IS A RARE BUT POTENTIALLY FATAL COMPLICATION OF CHRONIC PERITONEAL DIALYSIS (PD), ASSOCIATED WITH HIGH MORBIDITY AND MORTALITY RANGING BETWEEN 20% AND 30%. IF NOT LEADING TO DEATH, THE INFLAMMATORY PROCESS USUALLY CAUSES IRREVERSIBLE DAMAGE TO THE PERITONEAL MEMBRANE WITH SUBSEQUENT DROPOUT FROM PD THERAPY (PERITONEAL DIALYSIS INTERNATIONAL, FEBRUARY 2009 VOL 29 NO SUPPLEMENT 2 S161-S165). THE MAIN FACTORS ASSOCIATED WITH THE DEVELOPMENT OF FUNGAL PERITONITIS INCLUDE PREVIOUS ANTIBIOTIC THERAPY. THIS PATIENT WAS RECEIVING ANTIBIOTIC THERAPY FOR REASONS UNRELATED TO PERITONEAL DIALYSIS, AND THERE HAS BEEN NO INDICATION IN THE MEDICAL RECORDS THAT THE DEVICE OR SOLUTIONS WERE DEFECTIVE OR MALFUNCTIONED. THIS EVENT OF SERIOUS INJURY (FUNGAL PERITONITIS) RESULTED FROM LIKELY AGGRESSIVE ANTIBIOTIC THERAPY LEADING TO FUNGAL PERITONITIS, IN A PT RECEIVING PERITONEAL DIALYSIS USING THE CYCLER. THERE IS NO INDICATION THE DEVICE(S) AND/OR SOLUTION CAUSED OR CONTRIBUTED TO THE PT'S FUNGAL PERITONITIS.

    Description of Event or Problem · 1

    REF: US #(B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS RECEIVED FROM THE PATIENT'S CLINIC. ON AN UNKNOWN DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR WOUND CARE OF SCROTAL AND SACRAL WOUNDS. ON (B)(6) 2014, THE PATIENT WAS HYPOTENSIVE PRIOR TO TREATMENT WITH A BP OF 106/66 INSTRUCTIONS WERE GIVEN OVER THE PHONE FOR THE PD NURSE TO DO A STAT DRAIN. THE PD EFFLUENT FLUID WAS SENT FOR A GRAM STAIN AND CULTURE AND SENSITIVITY. AFTER DRAIN 4 ON THAT DAY THE PD FLUID WAS AMBER IN COLOR. THE PATIENT'S BP POST TREATMENT WAS 125/83. HIS EFFLUENT PD SOLUTION REMAINED CLEAR UNTIL (B)(6) 2014 WHEN IT WAS REPORTED TO BE HAZY. ON (B)(6) 2014 THE PATIENT'S BREATH SOUNDS HAD CRACKLES AND WERE DIMINISHED. THE PATIENT WAS STARTED ON O2 AT 5 PER NASAL CANNULA WITH AN O2 SAT OF 100%. HIS PD FLUID REMAINED HAZY BP WAS 112/45. ON (B)(6) 2014, THE PATIENT'S PD FLUID REMAINED HAZY AND CLOUDY. THE PATIENT WAS AFEBRILE WITH A BP OF. 128/61. ON (B)(6) 2014, THE PATIENT'S O2 WAS DECREASED TO 2L PER NASAL CANNULA, AND A NEEDLE SIZE OPEN SORE WAS REPORTED AT THE CATHETER SITE. THE PD FLUID REMAINED HAZY. ON (B)(6) 2014, THE PATIENT'S O2 WAS INCREASED TO 5L PER NASAL CANNULA. THE PATIENT COMPLAINED OF ABDOMINAL PAIN WITH CLOUDY PD EFFLUENT FLUID. THE RESULT FOR FUNGAL PERITONITIS WAS ESTABLISHED ON (B)(6) 2014. THE PATIENT WAS AFEBRILE WITH A BP OF 125/61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143762 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DELFLEX SOLUTION 2 5%.| DELFLEX SOLUTION 4.25%.| LIBERTY CYCLER CASSETTE.