BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3950518 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01163
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PERFUSIONIST THAT SINCE THE PATIENT'S FIRST PUMP WAS EXCHANGED ON (B)(6) 2014 (REFERENCE MFR. REPORT #2916596-2014-01046), THE PATIENT HAS NOT BEEN CLINICALLY DOING WELL. THE PATIENT'S PUMP SPEED WAS ACCELERATED TO 10,000 RPM IN ORDER TO UNLOAD THE HEART. HIGH PULSATILITY WAS NOTED ACCORDING TO ARTERIAL LINE WITH PUMP SPEED AT 10,000 RPM. THE FLOW WAS READING "---", PUMP POWER WAS APPROPRIATE AND PL SEEMED ELEVATED. THE PATIENT'S LDH'S WERE ELEVATED TO 1000 AND BLOOD UREA NITROGEN (BUN) AND CREATININE WERE INCREASING. THE PATIENT'S INR WAS 1.7 WHERE IT HAD BEEN THERAPEUTIC OVER 2.0. THE PHYSICIAN DECIDED TO START A HEPARIN DRIP. IT WAS REPORTED BY THE VAD COORDINATOR ON (B)(6) 2014 THAT THE PATIENT WAS NOT AWAKE EVEN THOUGH SEDATION HAD BEEN TURNED OFF. THE HOSPITAL STAFF WAS CONSIDERING THE POSSIBILITY OF AORTIC INSUFFICIENCY OR MICRO-EMBOLI. HEAD CTS WERE TAKEN AND WERE NORMAL WITH NO OTHER INDICATIONS OF NEURO DAMAGE/STROKE. ON (B)(6) 2014, A RAMP STUDY WAS CONDUCTED TO INCREASE THE SPEED TO UNLOAD THE LEFT VENTRICLE. THERE WERE NO CHANGES FROM THE PUMP DATA TO THE PATIENT'S HEMODYNAMICS. ON (B)(6) 2014, THE PERFUSIONIST REPORTED THAT THE HOSPITAL STAFF ADMINISTERED TPA. THE PATIENT STILL HAS NOT WOKEN UP AND CONTINUES TO HAVE ELEVATED LDHS. IT WAS ALSO REPORTED THAT THE PATIENT IS HEPARIN-INDUCED THROMBOCYTOPENIA POSITIVE (HIT+). THE HOSPITAL STAFF KNEW OF THIS PRIOR TO THE PATIENT'S INITIAL IMPLANTATION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406886 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 141100

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| D NA.