BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K HEMODIALYSIS SYSTEM

    MDR report key: 3820785 · Received May 8, 2014

    Report

    Report Number
    2937457-2014-00791
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE CONCORD PLANT
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION. THE EVENT REPORTED ON THIS PATIENT INVOLVES FIVE SEPARATE PRODUCTS AND ASSOCIATED WITH MDR'S. ADE/MDR# 1713747-2014-99953, 8030665-2014-00361, 1713747-2014-00228 AND 3005162618-2014-00005.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DIALYSIS CLINIC THAT DURING THE LAST 10 MINUTES OF HEMODIALYSIS THE PATIENT STATED SHE DIDN'T FEEL WELL. THE PATIENT'S BLOOD PRESSURE WAS STABLE, PULSE WAS 34 ON THE MACHINE, A MANUAL PULSE TAKEN WAS IRREGULAR AND BRADYCARDIC, A BOLUS OF 100CC SALINE WAS GIVEN TO THE PATIENT WITH LITTLE EFFECT, AND 100CC MORE SALINE WAS GIVEN. THE PATIENT APPEARED TO EXPERIENCE A SEIZURE AND BECAME UNRESPONSIVE. CPR WAS INITIATED AND 911 WAS CALLED THE PATIENT WAS GIVEN APPROXIMATELY 700CC MORE SALINE DURING THE EVENT. CPR CONTINUED UNTIL THE AMBULANCE ARRIVED, AND SHE WAS TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279611 2008K HEMODIALYSIS SYSTEM KDI FRESENIUS MEDICAL CARE CONCORD PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 0.9% SALINE,| FRESENIUS COMBISET,| OPTIFLUX DIALYZER,| NATURALYTE