BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 3010241 · Received March 12, 2013

    Report

    Report Number
    2937457-2013-00017
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K093902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FRESENIUS REGIONAL EQUIPMENT SPECIALIST EVALUATION, ON (B)(4) 2012, ON THE MACHINE FOUND NO ISSUES OR FAILURES WITH OPERATION AND/OR CALIBRATIONS. A MEDICAL REVIEW OF THE INFORMATION OBTAINED INDICATED THE PATIENT WAS IN A HYPERTENSIVE CRISIS LEADING TO A CEREBROVASCULAR EVENT. THIS PATIENT HAD A PRE-EXISTING HISTORY OF CVA'S, WHICH PLACED HIM AT A HIGHER RISK FOR DEVELOPING FURTHER CVA'S. THE HYPERTENSIVE CRISIS EXPERIENCED BY THIS PATIENT WAS OR MAY HAVE BEEN THE RESULT OF POOR COMPLIANCE WITH HIS ANTIHYPERTENSIVE MEDICATIONS, LEADING TO A FATAL STROKE/CVA. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE HEMODIALYSIS NURSE REPORTED THE PATIENT STARTED EXPERIENCING STROKE-LIKE SYMPTOMS DURING THE HEMODIALYSIS TREATMENT AND WAS TRANSFERRED TO HOSPITAL AND SUBSEQUENTLY EXPIRED. PATIENT WAS NOTED TO BE HYPERTENSIVE (BP 208/114) PRIOR TO THE HEMODIALYSIS TREATMENT. PATIENT REPORTED THAT HE FORGOT TO TAKE HIS MEDICATION AND STATED HE FELT FINE. THE STAFF REPORTED THE DEVICE PASSED THE FUNCTION TESTS, CONDUCTIVITY, PH AND TEMPERATURE WERE WITHIN ACCEPTABLE RANGE PRIOR TO INITIATION OF THE TREATMENT. THE 08:27 HEMODIALYSIS TREATMENT STARTED. THE 08:33 PATIENT REMAINED HYPERTENSIVE BP 205/108, HR 82. PATIENT DECLINED TO TAKE HIS BP MEDICATIONS AND STATED HE WOULD TAKE IT AFTER THE TREATMENT. THE 10:33 BP 224/123, HR 83. ULTRAFILTRATION TURNED OFF. TOTAL FLUID REMOVED 1565 ML. STAFF REPORTS PATIENT ALMOST PASSED OUT. A 200 ML NORMAL SALINE GIVEN. THE 10:35 BP 237/141, HR 84. PATIENT WAS NOTED TO BE APHASIC, WITH EYES OPEN, UNABLE TO FOLLOW DIRECTION OR SQUEEZE NURSE'S HAND AND HAD CLAMMY SKIN. BLOOD WAS RETURNED AND 911 PARAMEDICS WERE CALLED FOR PATIENT'S "STROKE-LIKE SYMPTOMS." THE 10:55 PATIENT WAS ALERT BUT APHASIC. PARAMEDICS TRANSFERRED TO THE HOSPITAL WHERE HE EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104718 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008T

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| O| R| S FRESENIUS OPTIFLUX (B)(4)| BICARBONATE| SALINE| ACID CONCENTRATE 2251