BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 5541540 · Received April 1, 2016

    Report

    Report Number
    2937457-2016-00353
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 21, 2016
    Report Date
    April 14, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CAN NOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE PLANT INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S CONTACT REPORTED A (B)(6) YEAR OLD PERITONEAL DIALYSIS (PD) PATIENT CONTACTED TECHNICAL SERVICES ON (B)(6) 2016 FOR ASSISTANCE WITH MULTIPLE ALARM RECEIVED. PER PATIENT TREATMENT DATA PATIENT EXPERIENCED DRAIN ISSUES DURING TREATMENT. FOLLOW-UP WAS MADE WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), WHO STATED THE PATIENT SUCCESSFULLY RESOLVED THE REPORTED ISSUES. PDRN STATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT NOR NEEDED MEDICAL INTERVENTION PER REPORTED ISSUE. THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITH THE CYCLER WITHOUT FURTHER ISSUE. PDRN STATED THE PATIENT IS CURRENTLY IN THE HOSPITAL DUE TO A HAND SURGERY THAT IS NOT RELATED TO THERAPY OR THE CYCLER. THE PATIENT REMAINED ASYMPTOMATIC: DRAIN 0: 642ML, FILL 1: 2598ML, DRAIN 1: 2057ML, FILL 2: 2598ML, DRAIN 2: 4832ML, FILL 3: 2598ML, DRAIN 3: 2226ML, FILL 4: 2598ML, DRAIN 4: 3161ML. THE REPORTED DRAIN VOLUME OF 4832 WAS 186% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE OVERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197168 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR