BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HM II LVAS EUROPE

    MDR report key: 2051313 · Received April 6, 2011

    Report

    Report Number
    2916596-2011-00124
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE PUMP FOR ANALYSIS; HOWEVER, THE DEVICE IS STILL IMPLANTED AT THIS TIME. POWER TO THE PUMP HAS BEEN DISCONNECTED. 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. APPROXIMATELY 11 MONTHS POST-IMPLANT, THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF THREE DIFFERENT TYPES OF INFECTION AND POTENTIAL THROMBUS FORMATION IN THE PUMP. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH LYMPHOMA AND WAS BEING TREATED WITH RADIO AND CHEMOTHERAPY. CHEMOTHERAPY WAS SUSPENDED DUE TO TREATMENT OF THE INFECTIONS. THE DISTRIBUTOR WAS INFORMED THAT THE PATIENT WAS SLEEPING AND WOKEN BY RED HEART ALARMS. THE PUMP HAD STOPPED. CONNECTIONS WERE CHECKED AND THE SYSTEM CONTROLLER WAS EXCHANGED, WITH NO RESOLUTION OF THE ALARMS. THE PATIENT WAS SWITCHED TO BATTERY SUPPORT AND THE SYSTEM CONTROLLER WAS EXCHANGED ONCE MORE; HOWEVER, THE ALARMS PERSISTED AND THE PUMP DID NOT RESTART. A BOLUS OF HEPARIN WAS GIVEN TO THE PATIENT AND THE PUMP WAS DISCONNECTED FROM POWER. THE PUMP REMAINS IMPLANTED AT THIS TIME. THE PATIENT IS STABLE WITHOUT INOTROPES AND A DECISION ON HIS THERAPY WILL BE DECIDED BY THE HOSPITAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention