BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 5427441 · Received February 10, 2016

    Report

    Report Number
    2937457-2016-00147
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    December 23, 2015
    Report Date
    March 4, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    PT DATE OF BIRTH: (B)(6) 1943. MEDICAL RECORDS WERE REVIEWED BY POST MARKET SURVEILLANCE STAFF. BASED ON THE 22 PAGES OF MEDICAL RECORDS INFORMATION THE MEDICAL RECORDS DID NOT CONTAIN DIALYSIS TREATMENT RECORDS, PROGRESS NOTES, PHYSICIAN ORDERS, MEDICATION RECORDS OR ADDITIONAL LABORATORY RESULTS FOR REVIEW. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD SUPPORTING A POSSIBLE ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT OF SYNCOPE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE PROVIDED BY THE PATIENT'S DIALYSIS CENTER. IT APPEARED THAT THIS (B)(6) MALE 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 (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS HYPOTENSIVE, EXPERIENCED A SYNCOPAL EVENT, AND FELL. THE PATIENT¿S PD NURSE REPORTED THAT THE PATIENT WAS NOT DIALYZING AT THE TIME OF THE EVENT, AND THAT IT WAS RELATED TO THE PATIENT¿S CONGESTIVE HEART FAILURE. ON (B)(6) 2015, THE PATIENT WAS ADMITTED TO A HOSPITAL DUE TO NAUSEA, VOMITING, AND GENERALIZED WEAKNESS. DURING THE ADMISSION INTERVIEW, THE PATIENT REPORTED THAT HE HAS EXPERIENCED INCREASED BILATERAL LOWER EXTREMITY WEAKNESS AND FATIGUE OVER THE PAST TWO WEEKS PRIOR TO THE ADMISSION. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO HOME WITH ORDERS TO CONTINUE PD THERAPY.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S SPOUSE REPORTED HER HUSBAND WAS HOSPITALIZED FOR CARDIAC-RELATED ISSUES. FOLLOW-UP WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015 DUE TO A SYNCOPAL EPISODE AS A RESULT OF THE PATIENT'S PRE-EXISTING CONDITION (HYPOTENSION). THE REPORTED ISSUE WAS UNRELATED TO THE PATIENT'S DIALYSIS CYCLER PERITONEAL DIALYSIS REGIMEN. PER PDRN THE PATIENT HAD MANY PRE-EXISTING COMORBIDITIES AND WAS NOT DIALYZING DURING OR PRIOR TO THE SYNCOPAL EVENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO SURGERY PERFORMED WHILE THE PATIENT WAS HOSPITALIZED. PER THE PDRN, THE HOSPITAL MEDICAL RECORDS INDICATED THE PATIENT WAS ADMITTED FOR HYPERTENSION BUT THE INITIAL DIAGNOSIS WAS INCORRECT. PER THE PDRN THE PATIENT CONTINUED PERITONEAL DIALYSIS TREATMENTS WHILE HOSPITALIZED, THUS NO TREATMENTS WERE MISSED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 AND RESUMED CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITH THE CYCLER. MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84825 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R