BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYZER

    MDR report key: 3862387 · Received April 23, 2014

    Report

    Report Number
    1713747-2014-00207
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 28, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THIS EVENT REPORT IS RELATED TO FIVE SEPARATE PRODUCTS AND ASSOCIATED WITH MDR'S 1225714-2014-01573, 1225714-2014-01574, 8030665-2014-00315, 2937457-2014-00642 AND 1713747-2014-00207.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY A PT EXPERIENCED A CARDIAC ARREST DURING TREATMENT. PRIOR TO THE EVENT; IT WAS REPORTED THE PT WAS NOT FEELING WELL AND LOST CONSCIOUSNESS. THE PT SHOWED NO RESPONSE FROM THE ADMINISTRATION OF NORMAL SALINE BOLUS. THE PT HAD NO PULSE AND CPR WAS INITIATED. EMERGENCY MEDICAL SERVICE WAS CALLED, THE PT WAS CONNECTED TO A DEFIBRILLATOR, A HEART RHYTHM WAS DETECTED AND NO SHOCK WAS ADMINISTERED. THE PT WAS THEN TRANSPORTED TO THE HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245151 FRESENIUS DIALYZER FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R GRANUFLO| 2008K HEMODIALYSIS MACHINE| NATURLYTE| FRESENIUS COMBI SET| .9% SALINE SOLUTION