BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8611798 · Received May 15, 2019

    Report

    Report Number
    2916596-2019-02301
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    May 7, 2019
    Report Date
    August 23, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, H6, H8: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. FURTHERMORE, REVIEW OF THE LOG FILE PROVIDED BY THE ACCOUNT CONFIRMED LOW FLOW ALARMS AS WELL AS ELEVATIONS IN PUMP POWER AND FLOW; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION. THE SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6) 2019 THROUGH (B)(6) 2019. SEVERAL LOW FLOW HAZARD ALARMS WERE CAPTURED ON (B)(6) 2019 BETWEEN 3:04:43 AM AND 5:17:58 PM, WHEN THE ESTIMATED FLOW DROPPED BELOW THE THRESHOLD OF 2.5 LPM. ADDITIONALLY, TWO TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW WERE CAPTURED ON (B)(6) 2019 AT 12:31:51AM AND 5:12:35 PM, WHICH APPEARED TO BE ASSOCIATED WITH PI EVENTS. DESPITE THE OBSERVED ALARMS AND FLUCTUATIONS IN PUMP PARAMETERS, THE PUMP APPEARED TO FUNCTION AS INTENDED, OPERATING ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE HMII LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE IFU EXPLAINS THAT PUMP FLOW IS ESTIMATED FROM PUMP POWER AND NOTES THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. ADDITIONALLY, THIS DOCUMENT 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. FURTHERMORE, THE HMII IFU AND PATIENT HANDBOOK DESCRIBE ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD ALARM, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 2 YEARS AND 6 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 THAT THE PATIENT WAS ADMITTED FOR FALL AT HOME WITH PRESUMED SYNCOPE, WITH OVERT INJURY, SUBDURAL HEMATOMA AND RIGHT MANDIBULAR HEMATOMA. LOG FILES REVIEWED REVEALED NUMEROUS LOW FLOW EVENTS ON (B)(6) 2019 BETWEEN 3:04 A.M. AND 5:17 P.M. THESE ALARMS WERE TRIGGERED WHEN THE CALCULATED AVERAGE FLOW DROPS BELOW 2.5 LPM. LOG FILES ALSO REVEALED TWO UNSUSTAINED SPIKES IN POWER AND FLOW ON (B)(6) 2019 WHICH OCCURRED AT 12:31 A.M. AND 5:12 A.M; HOWEVER, THE MCS DEVICE APPEARS TO BE WORKING AS INTENDED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S SYNCOPE WAS TRIGGERED BY A MECHANICAL FALL, AND NOT HEMODYNAMIC EMBARRASSMENT NOR ARRHYTHMOGENIC. THE PUMP IS WORKING AS ANTICIPATED BUT VULNERABLE NECESSARILY ACUTELY OFF ANTICOAGULATION FOR A DEFINES PERIOD POST LIFE-THREATENING HEAD INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405248 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 IFS100205 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization