BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16036114 · Received December 22, 2022

    Report

    Report Number
    2916596-2022-15592
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 4, 2022
    Report Date
    January 3, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MFRS FOR ONGOING INFECTION: 2916596-2022-12961, 2916596-2022-15732. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    RELATED MFR NUMBERS FOR PATIENT'S INFECTION HISTORY: #2916596-2022-15732 #2916596-2022-14030 #2916596-2022-12961 #2916596-2022-13403 #2916596-2022-12952 #2916596-2022-12876 #2916596-2022-12887 #2916596-2022-12926 #2916596-2022-13811. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2022 FEELING FEBRILE, FEVER, CHILLS, SEVERE FATIGUE, AND ANXIOUS. PICC LINE WAS OUT AND THE PATIENT MISSED TWO DOSES OF ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT'S PICC LINE CAME OUT AT HOME AFTER TAKING A SHOWER ON (B)(6) 2022. ON (B)(6) 2022 THE PATIENT CAME IN AS AN OUTPATIENT TO HAVE THE PICC LINE REPLACED. ON (B)(6) 2022 THE PATIENT WAS A DIRECT ADMIT FROM HOME TO THE HOSPITAL DUE TO INCREASED DRAINAGE FROM STERNAL WOUND AND DRIVELINE SITE. ON (B)(6) 2022 BLOOD AND SUBSTERNAL WOUND CULTURES WERE POSITIVE AGAIN FOR PSEUDOMONAS (CS-169167; CS-173940). THE PATIENT WAS RESTARTED ON ZOSYN AT 4.5G EVERY 8 HOURS AND DOXYCYCLINE AND ON (B)(6) 2022 ALL CULTURES WERE NEGATIVE. THE PATIENT WAS DECLINED FOR A TRANSPLANT DUE TO ELEVATED BMI, ONGOING INFECTION, AND PULMONARY FUNCTION TESTS. ON (B)(6) 2022 THE CENTER TURNED THE PATIENT'S SPEED DOWN TO ASSESS FOR RECOVERY AND HOPES OF EXPLANT HOWEVER, THE CENTER DID NOT FEEL LIKE A TRANSPLANT WAS THE BEST OPTION AT THAT TIME. THE CENTER WAS GETTING A SECOND OPINION FOR TRANSPLANT VERSUS RE-IMPLANT AND INCREASED THE PATIENT'S SPEED FOR A SECOND CONSIDERATION. ON (B)(6) 2022 THE PATIENT PRESENTED TO THE 2ND TRANSPLANT CENTER WHERE THEY WERE DECLINE TRANSPLANT DUE TO BMI AND NEED TO ESTABLISH MENTAL HEALTH SERVICES FOR THE PATIENT. THE PATIENT WAS DISCHARGED HOME ON IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406541 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8176443 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H