BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4181382 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02665
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    FRESENIUS MEDICAL NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYCLER WAS NOT FORWARDED TO FAILURE ANALYSIS FOR AN INVESTIGATION; THE CYCLER WAS SENT TO PRODUCTION TO BE REFURBISHED. AS PER THE DHR, THE REFURBISHMENT PROCESS FOUND THAT THE CYCLER FUNCTIONED PROPERLY AND NO DISCREPANCIES WERE FOUND DURING THE REFURBISHMENT AND TESTING PROCEDURE. THE FMC PHARMACOVIGILIANCE PHYSICIAN CONCLUDES THE PT'S ANGINA EPISODES OCCURRED PRIOR, DURING AND AFTER HIS PD TREATMENTS AND WERE THEREFORE NOT TEMPORALLY RELATED TO HIGH DRAIN VOLUMES. THIS IS CONSISTENT WITH ONGOING ANGINA PECTORIS; SECONDARY TO THE PT'S UNDERLYING CARDIOVASCULAR DISEASE; IN A PT WITH A DOCUMENTED HISTORY OF 4 PREVIOUS MYOCARDIAL INFARCTIONS AND CORONARY ARTERY DISEASE WITH PREVIOUS CORONARY STENT PLACEMENT. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN 21 MARCH 2011 TO 11 MARCH 2013. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PT'S PERITONEAL DIALYSIS RN (PDRN) CALLED TECH SUPPORT REQUESTING A CYCLER REPLACEMENT DUE TO THE PT/USER OF THE FMC DIALYSIS DEVICE HAVING TWO OVERFILL EVENTS AND THE NEXT DAY PT DEVELOPED A CARDIAC PROBLEM. DURING FOLLOW UP, IT WAS INDICATED THE PT HAD A LONG STANDING HISTORY OF CARDIAC DISEASE THAT INCLUDES MULTIPLE MYOCARDIAL INFARCTIONS. THE PT HAD BEEN HOSPITALIZED FOR CARDIAC ISSUES AND CHEST PAIN PRIOR TO THE FMC NOTIFICATION OF THIS EVENTS. THE PDRN STATED THE PT HAD TWO OVERFILL EVENTS AND AFTERWARDS DEVELOPED ANGINA. SHE DID NOT KNOW THE DRAIN VOLUME OR DATE FOR THE FIRST EPISODE BUT STATED IT OCCURRED WITH THE OLDER SOFTWARE VERSION. THE NEXT DAY PT HAD ANGINA AND TOOK NITROGLYCERIN WITH RELIEF OF PAIN. NO HOSPITALIZATION. THIS CYCLER WAS REPLACED AFTER THE PT RECEIVED THE NOTIFICATION LETTER. THE SECOND INCIDENT OCCURRED (B)(6) 2012. PT WAS FILLED WITH 2800 ML AND HAD A DRAIN VOLUME OF 4750 ML. PT DEVELOPED ANGINA THE NEXT DAY AND WAS ADMITTED TO THE HOSPITAL. THE PT CONTINUED TO HAVE ANGINA DURING HOSPITALIZATION. PT WAS DISCHARGED AFTER A FEW DAYS WITH A NEW REGIMENT OF CARDIAC MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556879 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER, FKX FKX FRESENIUS MEDICAL NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization