BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 3476877 · Received November 7, 2013

    Report

    Report Number
    2916596-2013-01439
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    October 12, 2013
    Report Date
    October 12, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, THE REPORTED INCIDENT OF ABNORMAL PRESSURE READINGS WAS CONFIRMED. EVALUATION PERFORMED ON THE CONSOLE ISOLATED THE FAULT TO THE INSTALLED ANALOG POWER SUPPLY PRINTED CIRCUIT BOARD. REPLACING THE COMPONENT RESOLVED THE ISSUE, AND RESTORED THE DEVICE FUNCTIONALITY. EVALUATION PERFORMED ON THE PRINTED CIRCUIT BOARD REVEALED THAT PERFORMING THE PRESSURE TRANSDUCER ALIGNMENT TEST RESOLVED THE ERRONEOUS PRESSURE/VACUUM READINGS. THE SPECIFIC CAUSE OF THE PRESSURE/VACUUM DRIFT WAS NOT DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE 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 SUPPORTED WITH A PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) FOR BIVENTRICULAR SUPPORT. THE SURGEON REPORTED THAT THE PT WAS BEING SUPPORTED WITH DUAL DRIVE CONSOLE (DDC), SERIAL NUMBER (B)(4), WHEN THE EJECT PRESSURE DIGITAL READING STARTED TO READ ABNORMAL PRESSURE VALUES AND ABNORMAL VACUUM PRESSURES. PRESSURE AND VACUUM ALARMS ACCOMPANIED THE ABNORMAL VALUE READINGS. THE PVAD (SUPPORTED BY THE TOP MODULE OF THE DDC) WAS NOTED TO BE INADEQUATELY FILLING AND EMPTYING DDC 578 WAS EXCHANGED FOR DDC, SERIAL NUMBER (B)(4). DDC (B)(4) OPERATED NORMALLY AND SUPPORTED THE PT ADEQUATELY, HOWEVER, THE BATTERY LIGHT REMAINED ILLUMINATED ON THE TOP CONSOLE. THE PT THEN STARTED COUGHING VIGOROUSLY, AND THE TOP MODULE OF THE DDC WAS NOT ILLUMINATED. HAND PUMPING WAS STARTED BY THE NURSING STAFF. THE ELECTRICAL CONNECTION OF THE DDC WAS INSPECTED AND THE STAFF NOTICED THAT IT HAD BECOME DISLODGED. AFTER THE DDC WAS PLUGGED BACK IN, THE TOP MODULE REGAINED POWER. THE STAFF STOPPED HAND PUMPING AND SWITCHED THE PT BACK TO THE DDC. THE PT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576186 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC) DSQ: VENTRICULAR ASSIST DEVICE SYSTEM (DDC) DSQ THORATEC CORPORATION L10025-2600-005

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention