BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBETY CYCLER

    MDR report key: 3963927 · Received July 16, 2014

    Report

    Report Number
    2937457-2014-01645
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE PROVIDED AND HAVE BEEN REVIEWED BY POST MARKET CLINICIAN STAFF. PATIENT IS A (B)(6) MALE WITH ESRD ON PD WHO WAS HOSPITALIZED FOR CARDIAC ARREST. BASED ON THE 1 AVAILABLE MEDICAL RECORDS INFORMATION, IT APPEARS THAT ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE ER WITH SHORTNESS OF BREATH AND WORSENING CHEST PAIN. WHILE IN THE ER, THE PATIENT EXPERIENCED A CARDIAC ARREST AND ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION. THE PATIENT HAD AN EMERGENCY CARDIAC CATHETERIZATION WHICH SHOWED MULTI-VESSEL CORONARY ARTERY DISEASE. AN ECHO CARDIOGRAM SHOWED AN EJECTION FRACTION OF 20%-25% WITH GLOBAL HYPOKINESIS. THE PATIENT HAD AN INTRA-AORTIC BALLOON PUMP INSERTED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THREE PRIOR TO THIS ADMISSION THE PATIENT WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION. HE WAS MADE AWARE OF HIS SIGNIFICANT CARDIAC DISEASE WITH SIGNIFICANT CO-MORBIDITIES, BUT REFUSED INTERVENTION. THE EVENT HAS BEEN REPORTED AS A SERIOUS INJURY ALTHOUGH IT IS UNDETERMINED IF THERE IS REASONABLE SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE LIBERTY CYCLER AND THE EVENT. THERE IS NO HISTORY OF SPECIFIC PRODUCT MALFUNCTION OR THE PRODUCT BEING OUT OF SPECIFICATIONS. THIS EVENT IS BEING REPORTED TO FULFILL FEDERAL COMPLIANCE REQUIREMENTS SINCE THE DEVICE INVESTIGATION AHS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PATIENT WITH CONGESTIVE HEART FAILURE WAS HOSPITALIZED. THE FOLLOWING GIS BAED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S TREATMENT FACILITY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH WORSENING CHEST PAIN. THE PATIENT HAD KNOWN MULTI-VESSEL CORONARY ARTERY DISEASE (CAD) AND WAS ADVISED AND REFUSED TO UNDERGO A CORONARY ARTERY BYPASS GRAFT (CABG) AT THAT TIME. THE PATIENT HAD A CARDIAC ARREST AND ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION AND MECHANICAL VENTILATION. HE HAD AN EMERGENT CARDIAC CATHETERIZATION AND 2-D ECHO WHICH REVEALED MULTI-VESSEL CAD, AN EJECTION FRACTION OF BETWEEN 20 - 25% AND GLOBAL HYPOKINESIA. VASOPRESSORS AND INTRA-AORTIC BALLOON PUMP WERE STARTED AND THE PATIENT WAS TRANSFERRED TO THE ICU. HE BECAME FEBRILE AND WAS TREATED THERE FOR A GRAM POSITIVE COCCI WITH VANCOMYCIN AND MEROPENEM. THE PATIENT UNDERWENT TRIPLE BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415066 LIBETY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R LASIX| ZEMPLAR| LISINOPRIL| INSULIN| ASPRIN| DEFLEX PD SOLUTIONS| CAREVEDILOL| LIBERTY CYLE CASSETTE| ATORVASTATIN| VITAMIN D