BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3830721 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00720
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    December 27, 2013
    Report Date
    April 7, 2014
    Manufacturer
    THORATEC CORP.
    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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTION- (APPROXIMATE AGE OF DEVICE)- 9 MONTHS. BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION COULD NOT CONCLUSIVELY BE DETERMINED. ON (B)(6) 2014, THE PATIENT WAS ON IV ANTIBIOTICS AND DISCHARGED (REFERENCE THE MANUFACTURER¿S MEDWATCH # 2916596-2015-00072). THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    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 THE PT DROPPED THEIR SYSTEM CONTROLLER AND HAD POSITIVE CULTURES OF PSEUDOMONAS ON (B)(6) 2013. THE HOSPITAL STAFF FEELS THAT THE PT DROPPING THE SYSTEM CONTROLLER POSSIBLY CAUSED THE INFECTION. THE PT IS ON ANTIBIOTICS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE AN ONGOING DRIVELINE INFECTION AND WAS BEING TREATED WITH ORAL ANTIBIOTICS ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270990 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124412

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention