BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7048426 · Received November 21, 2017

    Report

    Report Number
    2916596-2017-02869
    Event Type
    Death
    Date Received
    November 21, 2017
    Date of Event
    October 30, 2017
    Report Date
    April 17, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 8 YEARS, 5 MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. BLEEDING, STROKE AND SEPSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2009. IT WAS REPORTED ON (B)(6) 2017 THAT PATIENT WAS AN INPATIENT WHO CAME IN WITH SEPSIS, SUSPECTED TO BE UTI. DURING ADMISSION, THE DOCTOR AND THE NURSE PRACTITIONER STATED THAT THEY COULD HEAR THE PUMP MAKING AN UNUSUAL SOUND, LIKE A ¿CLUNKING NOISE¿. THERE WAS NO PARAMETER CHANGES NOTED ON HISTORY GOING BACK TO THE PREVIOUS WEDNESDAY WHEN THE SYSTEM CONTROLLER HAD BEEN EXCHANGED DUE TO A SOFTWARE UPGRADE. THE PATIENT WAS NOT REPORTING ANY SYMPTOMS CONSISTENT WITH PUMP THROMBOSIS, WITH NO ALARMS OTHER THAN A DOUBLE POWER DISCONNECT WHICH WAS THE PATIENT¿S DOING WHEN THE PATIENT WAS CONFUSED OVERNIGHT. THE PATIENT¿S LACTATE DEHYDROGENASE WAS NOT ELEVATED AND WAS 310 U/L (B)(6)2017. A LOG FILE WAS REVIEWED BY A TECHNICAL SERVICE REPRESENTATIVE AND A NUMBER OF EVENTS ASSOCIATED WITH THE SYSTEM CONTROLLER SETUP WERE CONFIRMED. THE PUMP PARAMETERS WERE STABLE AND OPERATING OVER SIMILAR RANGES THROUGHOUT THE LOG FILE PERIOD. IT WAS REPORTED ON (B)(6) 2017 THAT THE PATIENT EXPIRED OF A BRAIN BLEED AND SUPPORT WAS WITHDRAWN. THE FAMILY DID NOT PURSUE AN AUTOPSY AND THE PATIENT WAS CREMATED. THE PUMP WILL NOT BE RETURNED. HER DEATH IS NOT BELIEVED TO HAVE BEEN PUMP RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830580 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death