BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE

    MDR report key: 6653364 · Received June 13, 2017

    Report

    Report Number
    6653364
    Event Type
    Death
    Date Received
    June 13, 2017
    Date of Event
    May 4, 2017
    Report Date
    June 12, 2017
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6)2017 PT CALLED VAD OFFICE C/O FATIGUE, LIGHTHEADEDNESS, INTERMITTENT EPISTAXIS AND HEMATURIA HE DESCRIBED AS "DARK BLOOD WITH CLOTS". HE WENT TO (B)(6) AT (B)(6) INR 5.9, HG 11, SCR. K 5.4. PT TRANSFERRED TO NMH. LDH ON ADMISSION 1770. LOG FILES SENT TO HW FOR ANALYSIS THAT SHOWED CONCERN FOR PUMP THROMBOSIS. ON (B)(6), FLOWS ON VAD INCREASING, PT TRANSFERRED TO ICU FOR CLOSER MONITORING. PT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) FOR HVAD PUMP EXCHANGE. IN OPERATING ROOM, A THROMBUS WAS IDENTIFIED IN THE LEFT VENTRICLE AND REMOVED. POST OPERATIVELY, PT WITH PROFOUND CARDIOGENIC VS SEPTIC SHOCK ON MAX DOSES OF LEVO, VASO, NEO, EPI, MILRINONE, INO. PT UNRESPONSIVE TO VERBAL OR PHYSICAL STIMULI. ON (B)(6) PT HAD WORSENING ACIDOSIS DESPITE AGGRESSIVE VOLUME RESUSCITATION, CONTINUING ON MULTIPLE DRIPS, AND NOW WITH ONGOING LOW FLOW VAD ALARMS. FAMILY MEETING WAS ARRANGED AND THE DECISION WAS MADE TO TRANSITION PATIENT TO COMFORT CARE AND WITHDRAW SUPPORT. PT DIED ON (B)(6)2017 WITH FAMILY AT BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420031 HEARTWARE HVAD DSQ HEARTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R| S