BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUNNELED LINE

    MDR report key: 21114864 · Received January 8, 2025

    Report

    Report Number
    MW5164492
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    January 2, 2025
    Report Date
    January 6, 2025
    Manufacturer
    UNKNOWN
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT INITIALS: (B)(6) DATE OF AWARENESS: 1/6/2025. PATIENT REMS ID:(B)(6). PROVIDER REMS ID: (B)(4). REPORTER: PATIENT CHART; PER 1/5/2025 DISCHARGE SUMMARY "54-YEAR-OLD FEMALE WITH HISTORY OF RAYNAUD'S AND SUSPECTED CREST (CALCINOSIS, RAYNAUD'S PHENOMENON, ESOPHAGEAL DYSFUNCTION, SCLERODACTYLY, AND TELANGIECTASISIAS) SYNDROME, OBESITY WITH OSA (OBSTRUCTIVE SLEEP APNEA) AND PULMONARY HYPERTENSION WHO PRESENTS AFTER FINDING HER TUNNELED LINE FOR REMODULIN DETACHED, SUBSEQUENTLY ADMITTED FOR NEW TUNNEL LINE PLACEMENT. HOSPITAL COURSE COMPLICATED BY HYPOTENSION, RESOLVED WITHOUT INTERVENTION. NO GROWTH ON BLOOD CULTURES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366893 TUNNELED LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female #1-NAME AND STRENGTH: ADEMPAS 1 MG TABLETS 90/BO: 1MG. #1-NDC # OR UNIQUE ID: (B)(4). #1-MANUFACTURER/COMPOUNDER: BAYER.#1-LOT#: 3721831.| #2-NAME AND STRENGTH: ADEMPAS 1.5 MG TABLETS 90/BO: 1.5MG.#2-NDC # OR UNIQUE ID: (B)(4).#2-MANUFACTURER/COMPOUNDER: BAYER.#2-LOT#: 3563618.