BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13569761 · Received February 21, 2022

    Report

    Report Number
    2916596-2022-00711
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 22, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO REPORT THE INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO REPORT THE INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED ELEVATED LACTATE DEHYDROGENASE (LDH), AS WELL AS A DIRECT CORRELATION TO HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED BY THE ACCOUNT ON (B)(6) 2022 THAT THE PATIENT HAD RISING LEVELS OF LACTATE DEHYDROGENASE (LDH) AND PLASMA FREE HEMOGLOBIN. LOG FILES WERE SUBMITTED FOR REVIEW AND APPEARED TO SHOW THE SYSTEM FUNCTIONING AS INTENDED. NO ATYPICAL ALARMS WERE CAPTURED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER NO ADDITIONAL INFORMATION WAS RECEIVED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), AND THE HM3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1, ("INTRODUCTION") LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS, INCLUDING HEMOLYSIS. THE IFU PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. SECTION 4, (¿SYSTEM MONITOR¿), DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THE IFU STATES THAT PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. THIS SECTION ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 7 OF THE IFU, ("ALARMS AND TROUBLESHOOTING"), AND SECTION 5 OF THE PATIENT HANDBOOK, ("ALARMS AND TROUBLESHOOTING"), ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SENT TO TECHNICAL SERVICES FOR REVIEW DUE TO A RISE IN THE PATIENT'S LACTATE DEHYDROGENASE LDH LEVELS AND PLASMA FREE HEMOGLOBIN (PFH) VALUES. THEIR LDH WAS REPORTED TO BE 1336 U/L AND PFH WAS AT 525 MG/DL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SENT TO TECHNICAL SERVICES FOR REVIEW DUE TO A RISE IN THE PATIENT'S LACTATE DEHYDROGENASE LDH LEVELS AND PLASMA FREE HEMOGLOBIN (PFH) VALUES. THEIR LDH WAS REPORTED TO BE 1336 U/L AND PFH WAS AT 525 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130191 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8240677 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other