BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU

    MDR report key: 8995182 · Received September 11, 2019

    Report

    Report Number
    2916596-2019-04186
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 24, 2019
    Report Date
    November 19, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSIONS: REVIEW OF THE GRAPH PROVIDED BY THE ACCOUNT CONFIRMED A FEW TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED A GRAPH CONTAINED APPROXIMATELY 11 HOURS OF DATA FROM 24AUG2019. A FEW TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW WERE OBSERVED RANGING APPROXIMATELY FROM 7.5-7.7 WATTS AND 9.0-10.5 LPM, RESPECTIVELY. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE DATA SHOWED THE PUMP OPERATING ABOVE THE LOW SPEED LIMIT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) (DOCUMENTS 112603, 111859, 110940) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 06MAR2012 VIA CUSTOMER ORDER S94895. THE HMII LVAS IFU EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER EVENTS HAVE BEEN REPORTED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT WAS BETTER AND THAT THE PUMP PARAMETERS WERE BACK IN A NORMAL RANGE.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON THE DEVICE. 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) 2012. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO LVAD POWER FLUCTUATIONS UP TO 7.7 WATTS AND FLOW FLUCTUATIONS UP TO 10 LITERS PER MINUTE. LOG FILES WERE ANALYZED AND BLOOD TESTS WERE PERFORMED. ARGATROBAN THERAPY WAS STARTED. NO ALARMS WERE NOTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792796 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 104912

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R