BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 15734776 · Received November 4, 2022

    Report

    Report Number
    2916596-2022-14634
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 14, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF DAMAGE TO THE PATIENT'S DRIVELINE CAN BE CONFIRMED BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS. THE ACCOUNT SUBMITTED LOG FILES FOR REVIEW. ANALYSIS OF THE SUBMITTED LOG FILES REVEALED MULTIPLE LOW VOLTAGE HAZARD ALARMS AND NO EXTERNAL POWER EVENTS (PI-2022-0163666-02). THE SYSTEM CONTINUED OPERATION ON THE BACKUP BATTERY UNTIL APPROPRIATE POWER SOURCES WERE RECONNECTED AS INTENDED, AND SUPPORT WAS NOT INTERRUPTED AS A RESULT OF THE EVENT. THE PUMP REMAINED ABOVE THE LOW-SPEED LIMIT AND APPEARED TO BE FUNCTIONING AS INTENDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE II LVAS PATIENT HANDBOOK IS CURRENTLY AVAILABLE. SECTION 4 OF THIS HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE;" HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THE HEARTMATE II LVAS IFU IS ALSO AVAILABLE. THE SECTION "SYSTEM OPERATIONS" DESCRIBES THE "DRIVELINE" AND 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.". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC FOR IMPAIRED INTEGRITY OF THEIR DRIVELINE WHICH WAS COVERED WITH SILICONE TAPE. IMAGES OF THE DRIVELINE WERE PROVIDED THAT SHOWED SUPERFICIAL DAMAGE. LOG FILES SHOWED NO INDICATION OF ANY DRIVELINE ISSUES. RESCUE TAPE WAS APPLIED TO THE DRIVELINE. THE PATIENT WAS REPORTED TO BE DOING FINE AND WAS MEETING HIS BUDDIES FOR A DRINK ON A DAILY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251049 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male