BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8883080 · Received August 12, 2019

    Report

    Report Number
    2916596-2019-03927
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 21, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE RASH WAS OVER THE PATIENT'S ENTIRE BODY AND IS SUSPECTED TO BE RELATED TO ONGOING INFECTION. BLOOD CULTURES WERE NEGATIVE ON (B)(6) 2019 FOR GREATER THAN 72 HOURS. THE PATIENT WILL BE TREATED FOR 42 DAYS AFTER THE NEGATIVE BLOOD CULTURE. THE RASH WAS IMPROVING EACH DAY AND THE PATIENT WILL STAY ON CEFAZOLIN 6 GRAMS PER DAY IV UNTIL (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE - 2 YEARS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR A RASH, ABDOMINAL PAIN AND LEUKOCYTOSIS. THE CAUSE OF THE RASH WAS REPORTED TO BE THE ONGOING IV ANTIBIOTICS THE PATIENT WAS ALREADY ON. THE PATIENT HAS BEEN SWITCHED TO CEFAZOLINE VIA IV AT 6 GRAMS PER DAY. ADDITIONAL INFORMATION RECEIVED ON 31JUL2019: PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019 AFTER BEING HOSPITALIZED ON (B)(6) 2019 FOR A RASH SECONDARY TO THE ONGOING USE OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679595 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5932322

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R