BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16923862 · Received May 12, 2023

    Report

    Report Number
    2916596-2023-02862
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 2, 2023
    Report Date
    July 13, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENT OF HEMOLYSIS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED EVENT OF ELEVATED PUMP POWER AND FLOW VALUES; HOWEVER, A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED. THE SUBMITTED LOG FILES CONTAINED EVENTS AND DATA FROM 01MAY2023 THROUGH 02MAY2023, AS WELL AS 17MAY2023 THROUGH 22MAY2023, PER THE TIMESTAMPS. ELEVATED PUMP POWER AND FLOW VALUES WERE CAPTURED FROM 01MAY2023 THROUGH 02MAY2023. IT SHOULD BE NOTED THAT THE MAJORITY OF THESE ELEVATED PARAMETERS WERE CAPTURED DURING PULSATILITY INDEX (PI) EVENTS. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AND OPERATED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI). IN REFERENCE TO POWER, 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. SECTION 4, "SYSTEM MONITOR", 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, ¿PATIENT CARE AND MANAGEMENT¿, EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS SECTION ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT A NON-DEVICE RELATED CAUSE FOR THE PATIENT'S HEMOLYSIS WAS NOT IDENTIFIED; HOWEVER, IT REPORTEDLY RESOLVED, AND THE PATIENT REMAINED STABLE. THE NEXT TREATMENT STEPS WOULD INCLUDE PALLIATIVE CARE. THE PATIENT WAS SCHEDULED TO LEAVE THE HOSPITAL BY (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 DUE TO VERY HIGH POWER CONSUMPTION AND CALCULATED FLOW. THE PATIENT WAS SYMPTOMATIC AND THE LABORATORY FINDINGS INDICATED ELEVATED LACTATE DEHYDROGENASE (LDH) AND HEMOLYSIS PARAMETER. IT WAS DECIDED THAT A LYSES PROTOCOL WOULD BE STARTED ON (B)(6) 2023. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357547 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106016

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization| R