BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008T HEMODIALYSIS SYSTEM W/BIBAG

    MDR report key: 7470818 · Received April 27, 2018

    Report

    Report Number
    2937457-2018-01177
    Event Type
    Death
    Date Received
    April 27, 2018
    Date of Event
    April 9, 2018
    Report Date
    August 24, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861100910
    PMA / PMN Number
    K121341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: ON 04/09/2018, A USER CENTER NURSE MANAGER REPORTED THAT THIS UNNAMED PATIENT EXPIRED SHORTLY AFTER EARLY TERMINATION OF HEMODIALYSIS (HD) TREATMENT. FIFTEEN MINUTES INTO TREATMENT (SCHEDULED LENGTH OF TREATMENT UNKNOWN), THE PATIENT¿S BLOOD PRESSURE DROPPED (VALUES UNKNOWN). THE BLOOD WAS RETURNED TO THE PATIENT (VOLUME UNKNOWN) AND TREATMENT WAS ENDED. ANOTHER CODE WAS CALLED BUT THE PATIENT EXPIRED AFTER BEING REMOVED FROM THE MACHINE (RESUSCITATIVE EFFORTS UNKNOWN). THERE WERE NO REPORTED DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. THE PATIENT WAS IN AN ACUTE FACILITY, WAS CHRONICALLY ILL AND IN CRITICAL CONDITION. ON THE MORNING OF THE DEATH, THE PATIENT HAD CODED SEVERAL TIMES DURING THE MORNING, HOWEVER, THE PATIENT WAS STILL ADVISED TO UNDERGO HD THERAPY ON THE 2008T MACHINE. THE MACHINE WAS SEQUESTERED PER HOSPITAL POLICY, BUT NO ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY WERE REPORTED FOR THIS MACHINE. THE MACHINE WAS EVALUATED AND FOUND TO BE FUNCTIONING AS PER SPECIFICATION. THE MACHINE WAS PLACED BACK INTO SERVICE. ADDITIONAL INFORMATION REGARDING THE PATIENT AND CAUSE OF DEATH WAS REQUESTED BUT NOT PROVIDED. THERE IS A TEMPORAL RELATIONSHIP BETWEEN THE PATIENT EVENT OF HYPOTENSION AND SUBSEQUENT DEATH AND HD TREATMENT ON THE 2008T MACHINE AS THE PATIENT WAS CONNECTED TO THE MACHINE WHEN THE HYPOTENSION OCCURRED. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE EVENT OF HYPOTENSION AND THE 2008T MACHINE. ADDITIONALLY, THE PATIENT WAS REPORTED AS BEING IN CRITICAL CONDITION HAVING CODED SEVERAL TIMES PRIOR TO START OF HD THERAPY. THERE WAS NO ALLEGATION OF A MACHINE DEFICIENCY OR MALFUNCTION AND AN EVALUATION OF THE MACHINE FOUND IT TO BE FUNCTIONING AS PER SPECIFICATION. THE MACHINE WAS SUBSEQUENTLY PLACED BACK INTO SERVICE. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE 2008T HEMODIALYSIS (HD) MACHINE WAS EVALUATED AT THE FACILITY BY THE FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) DUE TO THE REPORTED EVENT. THE RES EVALUATED THE MACHINE. THE MACHINE UNDERWENT FUNCTIONAL CHECKS AND ALL TESTS FOUND THE UNIT TO BE FUNCTIONING WITHIN SPECIFICATION AND NO REPAIRS WERE MADE. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED DEVICE SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCE'S, OR ANY ASSOCIATED REWORK DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL THE REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    A USER FACILITY NURSE MANAGER REPORTED A PATIENT WHO CODED DURING HEMODIALYSIS (HD) TREATMENT. THE PATIENT WAS IN AN ACUTE FACILITY AND WAS CHRONICALLY ILL AND IN CRITICAL CONDITION. THE PATIENT HAD EXPERIENCED SEVERAL CODES DURING THE MORNING, HOWEVER, WAS STILL ADVISED TO HAVE THEIR SCHEDULED DIALYSIS THERAPY. AT THE BEGINNING OF THE PATIENT¿S TREATMENT, THE PATIENT¿S BLOOD PRESSURE DROPPED AND THE PATIENT WAS REMOVED FROM THE MACHINE AND TREATMENT DISCONTINUED. THE NURSE MANAGER REPORTED THAT ANOTHER CODE WAS CALLED AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE MACHINE WAS SEQUESTERED AFTER THE EVENT. A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) WAS CALLED ONSITE TO PERFORM A MACHINE EVALUATION PER HOSPITAL POLICY. THE NURSE MANAGER STATED THAT THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY OR MALFUNCTION ON OR AGAINST THE MACHINE OR ANY FRESENIUS DEVICE(S). THE RES TECHNICIAN VERIFIED OPERATION OF THE MACHINE PERFORMED THE MACHINE FUNCTIONAL TESTS. THE MACHINE WAS PLACED BACK IN SERVICE. ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE EVENT WAS REQUESTED, HOWEVER, NOT PROVIDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312630 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 00840861100910

    Patients

    Seq Age Sex Outcome Treatment
    1 Death