BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 5447733 · Received February 19, 2016

    Report

    Report Number
    2937457-2016-00194
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    February 5, 2016
    Report Date
    March 17, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REVIEWED BY POST MARKET SURVEILLANCE STAFF. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD SUPPORTING A POSSIBLE ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT OF FLUID VOLUME OVERLOAD. HOWEVER, THERE IS A PLAUSIBLE ASSOCIATION WITH THE EVENT AND NON-COMPLIANCE WITH DIALYSIS THERAPY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. EXTERNAL, VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF ANY PHYSICAL DAMAGE. THE HEATER TRAY/SCALE WAS NOT OBSTRUCTED.TWO SIMULATED TREATMENTS WERE PERFORMED USING THE RECEIVED CYCLER, AND THERE WERE NO ALARMS THAT OCCURRED DURING TESTING. THE VALVE ACTUATION TEST, SYSTEM AIR LEAK TEST AND PATIENT SENSOR CALIBRATION CHECK PASSED. THE LOAD CELL VALUE AND VERIFICATION WAS WITHIN TOLERANCE. THERE WERE NO DISCREPANCIES ENCOUNTERED IN THE INTERNAL INSPECTION OF THE CYCLER. THE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THERE WERE NO REPORTED DEVICE MALFUNCTIONS THAT WOULD HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE PROVIDED BY THE PATIENT'S DIALYSIS CENTER. BASED ON THE 24 PAGES OF MEDICAL RECORDS INFORMATION IT APPEARS THIS (B)(6) FEMALE END STAGE RENAL PATIENT (ESRD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY BEING CARRIED OUT DAILY THROUGH DELFLEX VIA IP ROUTE WITH DOSE REGIMEN NOT REPORTED, STARTED DIALYSIS THERAPY ON AN UNKNOWN DATE IN (B)(6) 2013. ON (B)(6) 2016, THE PERITONEAL DIALYSIS (PD) PATIENT PRESENTED TO A HOSPITAL¿S EMERGENCY DEPARTMENT DUE TO UNKNOWN ABNORMAL LABS, WAS DIAGNOSED WITH INTRACTABLE VOMITING, AND WAS TREATED PROPHYLACTICALLY FOR PERITONITIS. ON AN UNKNOWN DATE DURING THE ADMISSION, THE PATIENT WAS ADMINISTERED VANCOMYCIN VIA INTRAPERITONEAL (IP) ROUTE, DOSE REGIMEN NOT REPORTED. REVIEW OF MEDICAL RECORDS REVEALED THAT DURING THE ADMISSION¿S NEPHROLOGY CONSULTATION AND PERITONEAL DIALYSIS NOTE, THE PATIENT STATED THAT SHE DID NOT WANT TO HAVE PD FLUID IN HER ABDOMEN DURING THE DAY AND THAT SHE HAS BEEN UNHAPPY WITH PD BECAUSE OF HAVING TO CARRY FLUID IN HER ABDOMEN AND THE INCONVENIENCE OF HAVING TO DO IT NIGHTLY. LABORATORY DATA FROM (B)(6) 2016 REVEALED HEMOGLOBIN 7.2, AND THE PATIENT WAS ADMINISTERED ONE UNIT OF PACKED RED BLOOD CELLS, AND THE HEMOGLOBIN IMPROVED TO 8.6 (UNKNOWN DATE). THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT WAS HOSPITALIZED FOR FLUID OVERLOAD FOLLOWING SEVERAL DAYS OF MISSED TREATMENTS AND AS A RESULT OF NON-COMPLIANCE WITH HER RENAL REPLACEMENT TREATMENTS. AS OF (B)(6) 2016, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND CONTINUED PERITONEAL DIALYSIS TREATMENTS USING THE CYCLER WITHOUT FURTHER ISSUE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED SHE WAS HOSPITALIZED DUE TO HER DIALYSIS CYCLER NOT WORKING PROPERLY. FOLLOW-UP WAS MADE WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), WHO STATED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 FOR FLUID OVERLOAD FOLLOWING SEVERAL DAYS OF MISSED TREATMENTS AND AS A RESULT OF NON-COMPLIANCE WITH HER PERITONEAL DIALYSIS TREATMENTS. PER THE PDRN THE PATIENT WAS TRAINED ON PERFORMING STAT DRAINS AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT REPORTED THE CYCLER WAS NOT PROPERLY FUNCTIONING AND DID NOT REVERT TO CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) TREATMENTS AS A RESULT OF THE ISSUES. IT WAS UNKNOWN HOW MANY TREATMENTS WERE MISSED PRIOR TO THE HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 AND CONTINUED PERITONEAL DIALYSIS TREATMENTS USING THE CYCLER WITHOUT FURTHER ISSUE. MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103521 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization