BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3820729 · Received May 7, 2014

    Report

    Report Number
    2937457-2014-00781
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    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

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MEDICAL RECORDS WILL NOT BE RECEIVED AND THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED TECHNICAL SUPPORT FOR AN UNRELATED ISSUE. DURING THE CALL SHE STATED SHE HAD BEEN HOSPITALIZED ON AN UNKNOWN DATE FOR AN UNKNOWN ISSUE. FOLLOW UP WITH THE PATIENT'S PERITONEAL DIALYSIS NURSE WAS DONE. THE NURSE REPORTED THE HOSPITALIZATION WAS FOR PATIENT COMPLAINT OF CHEST PAIN AND IT WAS LEARNED THE PT/INR LEVEL WAS SUB-THERAPEUTIC DUE TO PATIENT NON-ADHERENCE WITH THE MEDICAL REGIMEN. HE FURTHER REPORTS THE CHEST PAIN WAS NOT RELATED TO THE DIALYSIS TREATMENT AND DID NOT ALLEGE DEVICE MALFUNCTION AS THE CAUSE. THE CYCLER WAS NOT RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276686 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FRESENIUS PD SOLUTIONS| LIBERTY CYCLER CASSETTE