BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9512109 · Received December 23, 2019

    Report

    Report Number
    2916596-2019-05798
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    November 25, 2019
    Report Date
    February 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: THE SYSTEM CONTROLLER INVOLVED IN THE EVENT IS REPORTED UNDER MFR#: 2916596-2020-00931. MANUFACTURER'S INVESTIGATION CONCLUSION: NO SPECIFIC DEVICE-RELATED ISSUES OR ADVERSE EVENTS WERE REPORTED. THE PATIENT¿S PRIMARY SYSTEM CONTROLLER WAS EXCHANGED, AND THE REPORTED ALARMS RESOLVED. THE ACCOUNT REPORTED THAT THE PATIENT WAS IN THE OR AFTER DEVICE IMPLANT. THE PATIENT¿S MONITOR SHOWED REPLACE SYSTEM CONTROLLER AND DRIVELINE POWER FAULT ALARMS ACCOMPANIED BY A YELLOW BANNER. THE PATIENT¿S PRIMARY SYSTEM CONTROLLER WAS EXCHANGED, AND THE ALARMS DID NOT REAPPEAR. THE MODULAR CABLE WAS NOT EXCHANGED, AND THE DRIVELINE REPORTEDLY DID NOT DEMONSTRATE ANY COMPROMISED AREAS. THE PATIENT WAS REPORTEDLY STABLE AND DISCHARGED HOME WITH NO FURTHER ALARMS OR DEVICE-RELATED ISSUES. REFER TO MFR#: 2916596-2020-00931 FOR THE INVESTIGATION OF RETURNED SYSTEM CONTROLLER, HSC-080251. SUBMITTED LOG FILES APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED ABOVE THE LOW SPEED LIMIT WITH STABLE PARAMETERS. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. NO SPECIFIC DEVICE-RELATED ISSUES OR ADVERSE EVENTS WERE REPORTED; HOWEVER, THE HEARTMATE 3 LVAS IFU PROVIDES A LIST OF ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "REPLACE SYSTEM CONTROLLER" & "DRIVE LINE POWER FAULT" ALARMS ACCOMPANIED BY A YELLOW BANNER WHILE STILL IN THE OPERATION ROOM. THE VAD COORDINATOR NOTICED SMALL AMOUNTS OF DRIED BLOOD NEAR THE MODULAR CONNECTION OF THE DRIVE LINE. IT WAS ORIGINALLY BELIEVED THAT THE CAUSE OF THE ALARMS WAS DUE TO A TRUE DRIVE LINE FAULT. HOWEVER, THE VAD COORDINATOR REPLACED THE PATIENT'S CONTROLLER AND THE ALARMS DID NOT REAPPEAR. THE MODULAR CABLE WAS NOT EXCHANGED. THE PATIENT WAS DISCHARGED HOME WITH NO FURTHER ALARM OR DEVICE RELATED ISSUE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305078 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7244594 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR