BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3012397 · Received March 13, 2013

    Report

    Report Number
    2937457-2013-00025
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 14, 2013
    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

    DEVICE, TREATMENT, OR MEDICAL RECORDS HAVE NOT BEEN MADE AVAILABLE TO THE MFR AS OF THIS WRITING DESPITE MULTIPLE REQUESTS TO OBTAIN INFORMATION. A MEDICAL REVIEW WAS PERFORMED ON THE PT'S MEDICAL INFORMATION PROVIDED: THERE IS NO HISTORY OF CYCLER MALFUNCTION WHICH MAY HAVE CAUSED OR CONTRIBUTED TO AN EVENT OF INAPPROPRIATE DIALYSIS LEADING TO FLUID OVERLOAD. PT HAS A HISTORY OF CORONARY ARTERY DISEASE AND REQUIRED ANGIOPLASTY AND STENTING DURING THE MENTIONED HOSPITALIZATION. FLUID OVERLOAD MAY HAVE CONTRIBUTED TO HIS CARDIAC SYMPTOMS. THE DEVICE WILL BE EVALUATED AND A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION.

    Description of Event or Problem · 1

    PT REPORTED NOT FEELING WELL DUE TO CARDIAC RELATED HEALTH ISSUES AND HAD BEEN HOSPITALIZED (B)(6) 2012. DURING A FOLLOW-UP CALL, PT STATED HE WAS HOSPITALIZED DUE TO THE CYCLER NOT DRAINING HIM, LEAVING AT LEAST 500 ML OF FLUID AFTER EACH CYCLE UNTIL HE HAD "SO MUCH FLUID IN HIM." PT'S PD NURSE INDICATED THE PT HAD DRAIN ISSUES WITH THE CYCLER BUT CANNOT SAY IF THE CYCLER CAUSED OR CONTRIBUTED TO THE PT'S HOSPITALIZATION EVENT. THE DIALYSIS UNIT'S CLINICAL COORDINATOR STATED THAT PT'S HOSPITALIZATION EVENT WAS NOT DUE TO THE CYCLER. PT WAS HOSPITALIZED DUE TO A HEART BLOCKAGE, REQUIRED A STENT PLACEMENT, AND BYPASS SURGERY. THE CLINICAL COORDINATOR ALSO INDICATED THE HOSPITALIZATION WAS NOT DUE TO THE CYCLER NOT DRAINING COMPLETELY AND NOT DUE TO FLUID RETENTION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106211 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTENSION SET| PD CATHETER| LIBERTY CYCLER TUBING SET| PD SOLUTIONS