BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3883605 · Received June 6, 2014

    Report

    Report Number
    2916596-2014-00901
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PATIENT. ALTHOUGH A ROOT CAUSE FOR THE REPORT OF A DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT WAS COMMUNICATED THAT THE PATIENT SHOWERED WITHOUT DRESSING HIS EXIT SITE WOUND. THE PATIENT WAS DISCHARGED TO HOME WITH ORAL ANTIBIOTICS AND NO FURTHER ISSUES HAVE BEEN REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE PUMP MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS SEEN IN THE CLINIC FOR A POTENTIAL DRIVELINE INFECTION. THE PATIENT STATED THAT HE TOOK A SHOWER WITHOUT USING A DRESSING OVER HIS WOUND. A LARGE AMOUNT OF GREEN DRAINAGE FROM THE DRIVELINE SITE WAS FOUND. THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR A CT OF THE ABDOMEN TO RULE OUT AN ABSCESS AND IV ANTIBIOTICS WERE ADMINISTERED. NO ABDOMINAL ABSCESS WAS SEEN ON THE CT SCAN, THE PATIENT HAD A DRIVELINE INFECTION. IT WAS REPORTED 6 DAYS LATER THAT THE PATIENT WAS DISCHARGED TO HOME WITH ORAL ANTIBIOTICS FOR A DRIVELINE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331353 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 89207

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention