BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 17436222 · Received August 1, 2023

    Report

    Report Number
    2916596-2023-05397
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 25, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILE DID NOT CAPTURE THE REPORTED ELEVATED PUMP POWER AND FLOW. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED DROP IN HEMOGLOBIN COULD NOT BE CONCLUSIVELY ESTABLISHED. A LOG FILE WAS SUBMITTED AND REVIEWED WHICH CAPTURED NUMEROUS PI EVENTS. NO OTHER UNUSUAL EVENTS OR ALARMS WERE CAPTURED AND THE DEVICE OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILE. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE SENT TO THE CUSTOMER; HOWEVER, NO INFORMATION HAS BEEN PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS. NO PRODUCT AVAILABLE FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS BLEEDING AS AN ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. SECTION 1 ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP POWER AND FLOW. THIS SECTION 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. IN ADDITION, DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. THIS SECTION ALSO NOTES THAT ANY INCREASE IN POWER NOT RELATED TO INCREASED FLOW CAUSES ERRONEOUSLY HIGH FLOW READINGS. THE IFU EXPLAINS THAT IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED WILL AUTOMATICALLY REDUCE TO THE LOW SPEED LIMIT AND SLOWLY RAMP BACK UP TO THE FIXED SPEED SETPOINT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿PUMP PERFORMANCE MONITORING¿), EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS SECTION ALSO PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A DROP IN HEMOGLOBIN AS WELL AS ELEVATED POWERS AND FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343131 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 105306

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other