BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K HEMODIALYSIS SYSTEM OLC/DIASAFE PLUS

    MDR report key: 4230619 · Received October 24, 2014

    Report

    Report Number
    2937457-2014-03032
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    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. BASED ON THE INFO PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REVIEWING PT MEDICAL RECORDS AND A PLANT INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CLINICAL STAFF'S ASSESSMENT OF THE REPORTED INFO AND THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT PT SUDDENLY BECAME UNRESPONSIVE, APPEARED TO HAVE SEIZURE LIKE ACTIVITY. DIALYSIS TREATMENT STOPPED, CONTINUED TO CIRCULATE BLOOD, NS BOLUS GIVEN, CHAIR TO SUPINE POSITION. NO PULSE DETECTED AND COMPRESSIONS WERE STARTED. CODE BLUE CALLED. FOUR SHOCKS WERE GIVEN AND PT CONVERTED INTO SINUS RHYTHM AND WAS HAVING A RHYTHM OF SINUS TACHYCARDIA ON THE MONITOR. SHE WAS ALSO BREATHING ON HER OWN. SUCTIONS WERE DONE TO REMOVE SECRETIONS FROM THROAT. THE PT WAS TRANSFERRED BY AIR AMBULANCE TO (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678336 FRESENIUS 2008K HEMODIALYSIS SYSTEM OLC/DIASAFE PLUS KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R NATURALYTE| FRESENIUS DIALYZER| CITRASATE ACID CONCENTRATE| CUSTOM COMBISET