BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12128646 · Received July 7, 2021

    Report

    Report Number
    2916596-2021-03343
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    January 24, 2021
    Report Date
    September 23, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-024105, AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 WITH CHEST PAIN, A FEVER, AND BACTEREMIA. THE ORIGIN OF BACTEREMIA WAS NOT IDENTIFIED. ANTIBIOTICS WERE STARTED; HOWEVER, THE PATIENT'S RENAL FUNCTION WORSENED. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED ON 27JAN2021 WHEN CREATINE WAS 4.5. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS STOPPED ON 23FEB2021. REPEAT BLOOD CULTURES WERE NEGATIVE AFTER COMPLETING COURSE OF ANTIBIOTICS. THE PATIENT WAS DEEMED STABLE FOR DISCHARGE ON (B)(6) 2021. THE PATIENT REMAINED ONGOING WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-024105, UNTIL THE PATIENT EXPERIENCED ADDITIONAL INFECTIONS (MFR. #2916596-2021-03280 AND MFR. #2916596-2021-03588). THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) LISTS INFECTION (LOCALIZED, DRIVELINE, PUMP POCKET, OR PSEUDO POCKET) AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK BOTH OUTLINE CARE INSTRUCTIONS FOR PREVENTING INFECTION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-024105 INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, WERE REVIEWED, AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2021 WITH CHEST PAIN, FEVER AND BACTEREMIA (STREP). THE ORIGIN OF THE BACTEREMIA WAS NOT IDENTIFIED. PENICILLIN WAS STARTED AND THE PATIENT'S RENAL FUNCTION WORSENED. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED ON (B)(6) 2021 WHEN CREATININE 4.5. CRRT WAS STOPPED ON (B)(6) 2021. REPEAT BLOOD CULTURES WERE NEGATIVE AFTER COMPLETING COURSE OF PENICILLIN. THE PATIENT WAS DEEMED STABLE FOR DISCHARGE ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026803 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7675708 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R