BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3830719 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00722
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 24, 2014
    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

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION AS THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) WAS NOT RETURNED TO THE MANUFACTURER. IT WAS REPORTED THAT THE PATIENT HAD A DEBRIDEMENT FOR DRIVELINE INFECTION; HOWEVER, FOLLOWING THE DEBRIDEMENT, THE PATIENT STILL HAD POSITIVE BLOOD CULTURES. IT WAS ALSO REPORTED THAT THE PATIENT REMAINED ONGOING ON PUMP SUPPORT UNTIL BEING ROUTINELY TRANSPLANTED ON (B)(6) 2014. BASED ON THE REPORT, THE PUMP WAS OPERATING AS INTENDED AT THE TIME OF THE TRANSPLANT. THE PUMP WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. 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 HAD A DEBRIDEMENT FOR A DRIVELINE INFECTION ON 03/24/2014 AND STILL HAS POSITIVE BLOOD CULTURES. THE HOSPITAL STAFF IS LOOKING TO MOVE THE PT UP ON THE TRANSPLANT LIST. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271297 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105453

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention