BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 3166090 · Received June 7, 2013

    Report

    Report Number
    2937457-2013-00076
    Event Type
    Death
    Date Received
    June 7, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2013 TECHNICAL SUPPORT RECEIVED A CALL FROM USER FACILITY FOR REQUEST OF MACHINE EVALUATION FOLLOWING ADVERSE EVENT DURING DIALYSIS (CHILLS, TACHYCARDIA). MEDICAL RECORDS WERE REVIEWED. ON (B)(6) 2013 THE HEMODIALYSIS TREATMENT STARTED AT 10:20 AM. THE PRE-TREATMENT VITAL SIGNS WERE: BLOOD PRESSURE 142/76, TEMPERATURE: 98.4 F, WEIGHT (B)(6). AT 12:35 THE PT COMPLAINED OF CHILLS AND AT THAT TIME THE PT'S PULSE WAS 121, TEMPERATURE: 98.7 F WITH UF REMOVED OF 419 ML. THE TREATMENT WAS INTERRUPTED ABRUPTLY AT 12:45 BECAUSE THE PT WAS FOUND UNRESPONSIVE. CPR WAS INITIATED, AED WAS PLACED AND A SHOCK WAS DELIVERED. NORMAL SALINE 900MLS GIVEN. THE PT REMAINED APNEIC. EMS CONTINUED CPR AND INTUBATED THE PT WITH AN ENDOTRACHEAL TUBE. IV EPI X3 WERE GIVEN. THE PT MONITOR SHOWED COARSE VENTRICULAR FIBRILATION. THE PT EXPIRED AT 13:43 PM THAT DAY. BASED ON THE MEDICAL RECORDS PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH MEDICAL RECORDS WERE PROVIDED, THE EXACT CAUSE OF DEATH IS UNK AND THE ER ADMISSION WAS NOT PROVIDED. ADDITIONAL, AN AUTOPSY REPORT OR DEATH CERTIFICATE HAS NOT BEEN PROVIDED. CURRENTLY, THE MFG PLANT INVESTIGATION IS STILL ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE PLANT INVESTIGATION IS COMPLETE. REFERENCE MDR #'S: 173747-2013-9908, 8030665-2013-00368. 1713746-2013-00181, 2937457-2013-00076, 3005162618-2013-00009.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY TO THE MFR ON (B)(6) 2013. THE PT HAD COMPLAINTS OF CHILLS AND TACHYCARDIA DURING TREATMENT. PT REQUESTED TO END HEMODIALYSIS EARLY. PT BECAME UNRESPONSIVE, 911 ACTIVATED. CPR PERFORMED. PT TRANSFERRED TO THE EMERGENCY ROOM VIA EMS PATIENT EXPIRED AT THE HOSPITAL. ON (B)(6) 2013 THE MANUFACTURER RECEIVED A USER FACILITY MEDWATCH FORM THAT REPORTED THE SAME EVENT AS NOTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253881 FRESENIUS DIALYSIS DELIVERY SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008 K2

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| L| R FRESENIUS NORMAL SALINE| FRESENIUS BLOODLINES| FRESENIUS DIALYZER OPTIFIX 160NRE| FRESENIUS DUAKTSATE (2K 2.5CA)