BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9221103 · Received October 22, 2019

    Report

    Report Number
    2916596-2019-04838
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    August 5, 2019
    Report Date
    November 12, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A DRIVELINE INFECTION. ON (B)(6) 2019 THE PATIENT WAS ADMITTED FROM EMERGENCY DEPARTMENT FOR DRIVE LINE DRAINAGE, SUBJECTIVE FEVER, CHILLS, ABDOMINAL PAIN. INFECTIOUS WORK-UP WAS STARTED. ON (B)(6) 2019 THERE WAS ONGOING INFECTIOUS WORK-UP. PATIENT RECEIVED 250 ML ALBUMIN X1 DOSE, PENDING CULTURES, CONTINUED BROAD SPECTRUM ANTIBIOTIC, COMPUTED TOMOGRAPHY (CT) WAS READ, DR. (B)(6) TO REVIEW. ON (B)(6) 2019 THERE WAS ONGOING INFECTIOUS WORK-UP. PATIENT WAS CLINICALLY IMPROVING. COMPUTED TOMOGRAPHY REVIEWED WITH CARDIO-THORACIC (CT) SURGERY AND HF, NO FURTHER INTERVENTIONS NECESSARY. PLANNED TO DISCHARGE HOME FRIDAY (B)(6) 2019 ON ORAL ANTIBIOTICS ONCE SUSCEPTIBILITIES RESULT (GRAM-NEGATIVE BACILLI (GNB) & GRAM-POSITIVE COCCI (GPC)) WAS RETURNED. ON (B)(6) 2019 DRIVELINE CULTURE POSITIVE FOR GPC, GNC AND ENTEROBACTER CLOACAE COMPLEX. BLOOD CULTURES WITH NO GROWTH TO DATE, STILL AWAITING SUSCEPTIBILITIES. ELECTROLYTES WERE REPLETED. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND HHS WERE CONSIDERED FOR INFUSIONS. ON (B)(6) 2019 DOPPLER MEAN ARTERIAL PRESSURES (MAP) WERE IN THE 95-100 MMHG RANGE. LOSARTAN WAS INCREASED TO 100 MG DAILY. HEART FAILURE SURGEON PLANNED TO REVIEW TRANSTHORACIC ECHOCARDIOGRAM (TTE). PATIENT EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) OVERNIGHT. PATIENT WAS ASYMPTOMATIC. CULTURES PENDING SUSCEPTIBILITY. CTM. PLANNED TO DISCHARGED PATIENT ONCE ANTIBIOTIC PLAN WAS ESTABLISHED. ON (B)(6) 2019 THE CULTURE SUSCEPTIBILITIES WERE RECEIVED. CEFEPIME WAS DISCONTINUED. PATIENT WAS STARTED ON CIPRO 500 MG BY MOUTH TWICE DAILY, DECREASED K-DUR 20 MEG DAILY. PATIENT'S INR WAS 1.8. COUMADIN WAS INCREASED TO 3 MG EVERY NIGHT AT BEDTIME. PATIENT WAS DISCHARGED AND WAS HOME STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015069 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524US 6807678 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L