BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 2864733 · Received December 6, 2012

    Report

    Report Number
    2916596-2012-01189
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 10, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO 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 PT WAS IMPLANTED WITH BI-VENTRICULAR SUPPORT. IT WAS REPORTED BY THE PERFUSIONIST THAT TINY CRACKS WERE NOTED AT THE CIRCUMFERENCE OF THE PVAD RVAD PUMP ON THE SUPERIOR SIDE OF THE RING. CRACKS WERE NOTED TO BE 2 MM ORIGINATING AT THE TOP OF THE RING. THE PT IS STABLE AND NO ALARMS WERE PRESENT. THERE WERE NO REPORTED DROPS OR CHANGES IN VACUUM AND PRESSURES. ADDITIONAL INFO RECEIVED CONFIRMED THAT THE PT UNDERWENT A PUMP EXCHANGE FROM ONE PVAD RVAD TO ANOTHER PVAD RVAD ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 103772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention