BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMS DELTEC CADD PRIZM

    MDR report key: 17011034 · Received May 25, 2023

    Report

    Report Number
    MW5117913
    Event Type
    Death
    Date Received
    May 25, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 23, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CTB (CEASED TO BREATHE) SHORTLY AFTER THE MVA (MOTOR VEHICLE ACCIDENT). PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT. WHEN PARAMEDICS ARRIVED IT WAS OBSERVED THAT MILRINONE BAG APPEARED EMPTY. PUMP STATED THERE WAS 9.5ML REMAINING IN THE BAG. PATIENT CTB SHORTLY AFTER THE MVA. ACUTE ON CHRONIC CONGESTIVE HEART FAILURE. (B)(6) STAGE D. VT (VENTRICULAR TACHYCARDIA) WHICH REQUIRED DEFIBRILLATION, PAROXYSMAL A-FIB, PALLIATIVE INOTROPE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650212 SIMS DELTEC CADD PRIZM PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6100

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death MILRINONE