BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC

    MDR report key: 372275 · Received January 15, 2002

    Report

    Report Number
    372275
    Event Type
    Death
    Date Received
    January 15, 2002
    Date of Event
    January 5, 2002
    Report Date
    January 14, 2002
    Manufacturer
    THORATEC LABORATORIES CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PT WHO WAS ON A TRANSPLANT LIST FOR DILATED IDIOPATHIC CARDIOMYOPATHY AND WAS ON A BIVENTRICULAR ASSIST DEVICE. IN THE EVENING IN 2002, A GRINDING NOISE WAS HEARD COMING FROM THE PORTABLE THORATIC SYSTEM TO THE STANDARD THORATEC SYSTEM AT THE BEDSIDE. PT IMMEDIATELY BECAME AGITATED AND SHORT OF BREATH. A BLUE ALERT WAS CALLED. THE PT DEVELOPED PULMONARY EDEMA. WAS INTUBATED AND PLACED ON A VENTILATOR AND TRANSFERRED TO THE CORONARY CARE UNIT. DURING THE CODE, IT WAS DISCOVERED THAT THE LEFT AND RIGHT DRIVE LINES CONNECTED TO THE BACK OF THE STANDARD THORATEC SYSTEM WERE CONNECTED BACKWARDS. THE PT EXPIRED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC THORATEC DUAL DRIVER CONSOLE DSQ THORATEC LABORATORIES CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death