BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2921719 · Received January 15, 2013

    Report

    Report Number
    2916596-2013-00051
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT SHE WENT TO CHECK ON THE PT SINCE THE PT HAD NOT BEEN ABLE TO COME TO THE CLINIC. THE PT HAD GAINED 17 LBS, HAD PITTED EDEMA, AND SHORTNESS OF BREATH (WHILE ON 2L OF OXYGEN). THE PT WAS ALSO ON AN ANTIBIOTIC FOR A POSSIBLE URINARY TRACT INFECTION (UTI), AFTER THE PT HAD TO GET A FOLEY CATHETER WHILE PREVIOUSLY IN THE HOSPITAL. THE PT'S DRIVELINE SITE WAS CHECKED AND LOOKED GOOD; THERE WAS NO REDNESS OR DRAINAGE, AND THE PT DID NOT HAVE ANY FEVER. THE PT WAS READMITTED INTO THE HOSPITAL AFTER THE VAD COORDINATOR REPORTED THAT THE PT DID NOT SEEM WELL DURING HER VISIT. WHEN THE PT SENT INTO THE HOSPITAL, THE PT WAS PLACED ON BIPHASIC POSITIVE AIRWAY PRESSURE (BIPAP) AND WAS LATER REINTUBATED. THE PT'S INR WAS 3.8 (NORMALLY 2.0-2.5), BLOOD UREA NITROGEN (BUN) 108, CREATININE WAS 2.4 WITH "COKE-COLORED URINE." THE PT'S PUMP SPEED WAS INCREASED AND WAS ADMINISTERED MEDICATION. ADD'L INFO WAS RECEIVED FROM THE VAD COORDINATOR THAT THE PT HAD A TRACHEOSTOMY AND PEG PLACED SINCE THEY WERE UNABLE TO SUCCESSFULLY WEAN HIM OFF OF THE VENTILATOR WHEN INTUBATED AND HAD RECURRENT ISSUES OF BEING INTUBATED SINCE IMPLANT. IT WAS ALSO REPORTED THAT THE PT DID HAVE RENAL FAILURE AND NOT HEMOLYSIS. AN ECHO WAS PERFORMED AND DID NOT SHOW ANY THROMBUS, AND THE PT'S KIDNEY FUNCTION IS NOW GOOD. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22107 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 118913

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention