BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8336606 · Received February 13, 2019

    Report

    Report Number
    2916596-2019-00591
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 3, 2019
    Report Date
    April 26, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF A LOW SPEED AND PUMP STOP EVENTS CAN BE CONFIRMED BASED ON THE SUBMITTED LOG FILE. THE LOG FILE CAPTURED SEVERAL LOW-SPEED EVENTS AND 2 PUMP WHILE THE PATIENT WAS SUPPORTED BY THE PATIENT CABLE AND MPU. BASED ON PAST HISTORY AND SIMILARLY REPORTED EVENTS, THE DATA CAPTURED IN THE LOG FILE IS POTENTIALLY CONSISTENT WITH A DAMAGED WIRE IN THE PATIENT¿S DRIVELINE; HOWEVER, A SPECIFIC CAUSE FOR THE LOW SPEED AND PUMP STOP EVENTS CANNOT BE CONCLUSIVELY DETERMINED. TECHNICAL SERVICES PERFORMED AN ONSITE DRIVELINE EVALUATION ON 05FEB2019. THE PATIENT WAS CONNECTED TO A GROUNDED PATIENT CABLE; HOWEVER, THE PUMP STOPS WERE UNABLE TO BE REPRODUCED WITH EXTERNAL DRIVELINE MANIPULATION AND UPPER BODY MOVEMENTS. THE CUSTOMER REQUESTED TWO UNGROUNDED PATIENT CABLES. THE PATIENT REMAINS ONGOING ON VAD SUPPORT USING AN UNGROUNDED PATIENT CABLE. NO PRODUCT AVAILABLE FOR INVESTIGATION. THE HEARTMATE II LVAS IFU OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE SECTION "EQUIPMENT STORAGE AND CARE" DESCRIBES "CARE OF THE DRIVELINE." THE SECTION "ALARMS AND TROUBLESHOOTING" OUTLINES ALARMS AND HOW TO RESPOND TO THEM, INCLUDING LOW FLOW, LOW SPEED, AND PUMP STOPS. THE HEARTMATE II LVAS PATIENT HANDBOOK CONTAINS INFORMATION ON ¿CARING FOR THE DRIVELINE.¿ HOWEVER, ALL HMII LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDING UPON THE LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 2 YEARS, 4 MONTHS. THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED ON (B)(6) 2019 THAT THE PATIENT HAD 2 PUMP STOP EVENTS AND LOG FILES WERE SUBMITTED. TECHNICAL SERVICE REVIEWED THE LOGS AND BETWEEN (B)(6) 2019 5:52 - (B)(6) 2019 23:41 CONFIRMED PUMP STOPS AND MULTIPLE LOW SPEED OPERATIONS WHICH DROPPED BELOW THE PATIENTS LOW SPEED LIMIT OF 9400 RPM. THIS TYPE OF BEHAVIOR HAS BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THESE ISSUES ONLY APPEAR TO BE OCCURRING WHILE THE VAD IS CONNECTED TO THE POWER MODULE AND MOBILE POWER UNIT. THE PATIENT WAS ADVISED TO STAY CONNECTED TO BATTERY POWER UNTIL FURTHER INVESTIGATION WAS COMPLETED. X-RAYS WERE SUBMITTED AND SHOWED SOME WEAR AND TEAR O HE EXTERNAL SECTION OF THE PERCUTANEOUS LEAD. ON (B)(6) 2019 IT WAS REPORTED THAT DURING ON SITE EVALUATION, UNABLE TO REPRODUCE MOTOR STOPPED EVENTS WITH EXTERNAL DRIVELINE MANIPULATION AND UPPER BODY MOVEMENT WHILE CONNECTED TO GROUNDED PATIENT CABLE. CUSTOMER REQUESTS THE USE OF (2) UNGROUNDED PATIENT CABLES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128125 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention