BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6119592 · Received November 21, 2016

    Report

    Report Number
    2916596-2016-02286
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 1, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 11 MONTHS. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT WAS RETURNED FOR EVALUATION. THE REPORT OF PUMP STOPPAGES WAS CONFIRMED BASED ON THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. THE LOG FILE CAPTURED A PUMP STOP AND DRIVELINE DISCONNECT ALARM ON (B)(6) 2016 AT 18:12. THE PUMP WAS RESTARTED APPROXIMATELY 9 SECONDS LATER AND RAN UNTIL (B)(6) 2016 18:14 WHEN MORE PUMP STOPS AND DRIVELINE DISCONNECTS WERE CAPTURED UNTIL THE LOG FILE ENDED ON (B)(6) 2016 18:19. REPORTEDLY, THE PATIENT TRIED TO ATTEMPT A SYSTEM CONTROLLER EXCHANGE WITHOUT GUIDANCE AND HAD DIFFICULTY FULLY CONNECTING THEIR DRIVELINE TO THE NEW SYSTEM CONTROLLER. THE PATIENT REPORTEDLY DISCONNECTED BOTH POWER CABLES, CAUSING THE EMERGENCY BACKUP BATTERY TO START. THEY THEN DISCONNECTED THEIR DRIVELINE TO ATTEMPT AN EXCHANGE. THEY RECONNECTED AND THEN ATTEMPTED ANOTHER EXCHANGE, AGAIN DISCONNECTING THE DRIVELINE, AND COMPLETING THE EXCHANGE. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT WITH NO FURTHER REPORTED ISSUES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT ON (B)(6) 2016, THAT THE PATIENT ATTEMPTED TO EXCHANGE THE SYSTEM CONTROLLER AFTER CONNECTING TO BATTERY POWER, AND THAT THE EXCHANGE WAS PERFORMED WITHOUT GUIDANCE FROM THE LVAD CLINICIANS. THE PATIENT HAD JUST EXCHANGED BATTERIES AT THAT TIME OF THE EXCHANGE. THE PATIENT WAS ASYMPTOMATIC. LOG FILE ANALYSIS PERFORMED BY THE MANUFACTURER¿S TECHNICAL SERVICES REPRESENTATIVE REVEALED MULTIPLE PUMP STOPPAGES AND SPEED DROP GREATER THAN 200 RPMS BELOW THE LOW SPEED LIMIT. IT WAS REPORTED THAT THE SPEED DROPS AND PUMP STOPPAGES WERE DUE TO THE PATIENT DISCONNECTING THE DRIVELINE WHEN REPLACING THE SYSTEM CONTROLLER WITHOUT GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768098 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention