BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR ASSIST DEVICE

    MDR report key: 4023441 · Received August 14, 2014

    Report

    Report Number
    2916596-2014-01411
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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

    ADDITIONAL INFORMATION: (B)(4). ALTHOUGH CRACKS IN THE PUMP HOUSING WERE CONFIRMED, A SPECIFIC ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED PUMP, MULTIPLE CRACKS RUNNING PERPENDICULAR TO THE THREADS WERE NOTED ON THE PUMP HOUSING; HOWEVER, NO EVIDENCE OF DAMAGE TO THE PUMP CAP OR PUMP HOUSING WAS NOTED. THE PUMP WAS PRESSURIZED AND TESTED FOR LEAKS ON BOTH THE BLOOD SAC AND THE PNEUMATIC SIDE OF THE PUMP. THE PUMP PASSED OUR MANUFACTURING SPECIFICATIONS AND THE CRACKING DID NOT AFFECT THE ABILITY OF THE DEVICE TO HOLD AIR. 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 VENTRICULAR ASSIST DEVICE. THE BIOMEDICAL ENGINEER REPORTED THAT THERE WERE CRACKS IN THE PUMP. THE CRACKS WERE FIRST NOTICED AS STABLE STRESS MARKINGS/FRACTURES. AFTER FIRST SEEING THEM, THE HOSPITAL DIDN'T SEE ANY MORE APPRECIABLE CRACKS, NOR DID THEY SEE THE CRACKS PROGRESSING. ON (B)(6) 2014 THEY SAW A LARGER CRACK. ON (B)(6) 2014, THE PT RECEIVED A PUMP EXCHANGE DUE TO SURGEON DECISION AND THE PT IS STABLE AND DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: LARGE CRACK ON LATERAL UNDERSIDE OF RVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488066 VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 126710

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention