BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSITE HS STEPPED TIP

    MDR report key: 6092072 · Received November 10, 2016

    Report

    Report Number
    3008110587-2016-00035
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MARVAO MEDICAL
    Product Code
    MSD
    UDI-DI
    05391525640020
    PMA / PMN Number
    K121933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE THE DEVICE WAS NOT REMOVED UPON THE PATIENT'S DEATH; THEREFORE AN ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE LOT MET THE SPECIFICATION REQUIREMENTS. THE REVIEW FOUND NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. TAKING INTO CONSIDERATION THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WAS ASSIGNED THE MOST PROBABLE ROOT CAUSE OF AN ANTICIPATED PROCEDURAL COMPLICATION. A COMPLAINT WITH A MOST PROBABLE ROOT CAUSE CLASSIFICATION OF AN ANTICIPATED PROCEDURAL COMPLICATION INDICATES THAT A DEVICE-RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE SITE HAS BEEN UNABLE TO GET A DEATH CERTIFICATE. THE DIALYSIS UNIT DID SEND OVER A REPORT WHICH STATES THE CAUSE OF DEATH AS "UNKNOWN". THE PATIENT WAS HOSPITALISED FOR THE SEPSIS EVENT THAT OCCURED ON (B)(6) 2016.

    Description of Event or Problem · 1

    (B)(4): THE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THIS CHRONICALLY ILL DIALYSIS PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT WITH LOW BLOOD PRESSURE, LOW GLUCOSE AND POSSIBLE SEPSIS. THE PATIENT REPORTED THAT SHE HAD NOT BEEN FEELING WELL ALL WEEK DUE TO NAUSEA AND MALAISE. SHE HAD BEEN SENT OVER TO THE ED FROM THE DIALYSIS UNIT. THE ED NOTE STATED THAT THE SUBJECT HAD NOT NOTICED ANY DRAINAGE OR TENDERNESS FROM THE CATHETER. SHE HAD RECEIVED A DOSE OF VANCOMYCIN FOR AN INFECTED DIALYSIS CATHETER. THE FILE NOTES FROM THE ED INDICATE THAT "SHE WAS INITIALLY HYPOTENSIVE AND GIVEN IV FLUIDS, SEPTIC PROTOCOL AND WORKUP. SHE HAD ELEVATED WHITE BLOOD CELL COUNT AND CHRONIC ANEMIA. SHE WAS HAVING RUNS OF ATRIAL FIBRILLATION BUT HER PRESSURE WAS LOW. A VERBAL ORDER WAS GIVEN FOR HER TO TAKE HER DAILY LOPRESSOR. HER LABS WERE DRAWN ON (B)(6) 2016 AND SHOWED ELEVATED LACTIC ACID, ELEVATED CREATININE AND NORMAL POTASSIUM. A PORTABLE CHEST X-RAY SHOWED MILD CONGESTIVE HEART FAILURE. WHEN IN THE ROOMS, THE PATIENT STOPPED BREATHING AND LOST HER PULSE. IMMEDIATELY CALLED A CODE BECAUSE SHE WAS ASYSTOLIC. SHE WAS INTUBATED WITH A 7-1/2 ET TUBE GLIDE SCOPE AND BOUGIE. THERE WAS A GOOD COLOUR CHANGE AND VENTILATION. SHE WAS GIVEN EPI CALCIUM BICARBONATE AND TEMPORARILY GOT A PULSE BACK AND WAS BRADYCARDIC IN THE 40S. EKG SHOWED JUNCTIONAL RHYTHM. SHE WAS STARTED ON "THAT B DRIP", GAVE HER A LOADING DOSE AND DRIP OF AMIODARONE. BLOOD PRESSURE WAS UNOBTAINABLE AT THAT POINT SO SHE WAS GIVEN LEVOTHYROID. THE PATIENT WAS RESUSCITATED AND REGAINED PULSE FOR A MINUTE OR 2 AND THEN WOULD GO BACK INTO ASYSTOLIC CARDIAC ARREST. AFTER 9 ROUNDS OF EPINEPHRINE CALCIUM GLUCOSE BICARBONATE, MULTIPLE REASSESSMENTS OF THE BEDSIDE WITH FAMILY PRESENT, ULTRASOUND MACHINE SHOWING NO CARDIAC ACTIVITY, CARDIAC ARREST WAS CALLED". THE DEVICE WAS NOT REMOVED ON THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    A CERTIFICATE OF DEATH WAS RECEIVED. THIS STATES THAT THE IMMEDIATE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST/SEPSIS/ESRD/CHF.

    Description of Event or Problem · 1

    CONCLUSIONS OF THE CEC (CLINICAL EVENTS COMMITTEE) FOLLOWING ADJUDICATION OF THE ADVERSE EVENT: A CRBSI EVENT POSSIBLY DEVICE RELATED RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745500 NEXSITE HS STEPPED TIP HEMOADIALYSIS CATHETER MSD MARVAO MEDICAL NEXHD1552801 42550 05391525640020

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death