BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3912889 · Received June 13, 2014

    Report

    Report Number
    2937457-2014-01021
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT OF THE TREATMENT DATA PROVIDED. A LARGE INTRA-PERITONEAL DRAIN VOLUME OCCURRED DURING CATHETER REPOSITIONING SURGERY DUE TO AN UNDERMINED CAUSE. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED. 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.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT WAS HOSPITALIZED ON (B)(6) 2014 DUE TO DRAIN COMPLICATIONS AND ABDOMINAL PAIN, SECONDARY TO OMENTAL WRAPPING OF THE PERITONEAL DIALYSIS CATHETER. DURING THE PATIENT'S ADMISSION, AN EMERGENT SURGERY WAS PERFORMED TO REPOSITION THE PERITONEAL DIALYSIS CATHETER. THE SURGEON DRAINED 7500ML FROM THE PERITONEAL DIALYSIS CATHETER DURING THE OPERATION. THE REPORTED DRAIN VOLUME OF 7500ML WAS 300% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNKNOWN DATE AFTER THE HOSPITALIZATION, THE PATIENT HAD HIS PERITONEAL DIALYSIS CATHETER REMOVED AND THE PATIENT'S TREATMENT MODALITY WAS CHANGED FROM PERITONEAL DIALYSIS TO HEMODIALYSIS. THE PATIENT'S MODALITY WAS CHANGED DUE TO THE FACT THAT THE PATIENT'S ANATOMY LEADING TO THE OCCURRENCE OF OMENTAL WRAPPING DID NOT MAKE HIM A CANDIDATE TO CONTINUE PERITONEAL DIALYSIS. AS OF (B)(6) 2014, THE PATIENT CONTINUES HEMODIALYSIS THERAPY WITHOUT FURTHER ISSUES, AND THE PATIENT'S COMPLAINT OF ABDOMINAL PAIN HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350121 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R LIBERTY CYCLER CASSETTE| DEFLEX PD SOLUTION