BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-HEART LOW FLOW NEBULIZER

    MDR report key: 525426 · Received April 22, 2004

    Report

    Report Number
    MW1031923
    Event Type
    Injury
    Date Received
    April 22, 2004
    Date of Event
    April 20, 2004
    Report Date
    April 22, 2004
    Manufacturer
    WEST MED, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED IN 2004 TO THE ICU IN STATUS ASTHMATICUS. THEY WERE STARTED ON CONTINUOUS ALBUTEROL NEBULIZATION AT A RATE OF 10 MG/HR. CONTINUED WITH WHEEZING AND SOB. THE NEXT DAY THE ALBUTEROL DOSE WAS INCREASED TO 12 MG/HR. THEY WERE INTUBATED THE FOLLOWING DAY AND CONTINUED ON ALBUTEROL 12 MG/HR. THEY CONTINUED WITH MINIMAL AIR EXCHANGE AND PEAK INSPIRATORY PRESSURE OF 35-42 AND TITAL VOLUME OF 400. THE FOLLOWING DAY THEY REQUIRED PARALYSIS TO HELP MAINTAIN OXYGENATION AND TO TOLERATE VENT SETTINGS. DURING THIS TIME IT WAS NOTED WITHIN THE CONTINUOUS NEBULIZATION DEVICE MINIHEART LOW FLOW NEBULIZER- THE LIQUID WAS FOAMING. SIX DAYS LATER, THE ALBUTEROL WAS CONVERTED TO XOPENEX AND THE FOAMING STOPPED. PT BEGAN DEMONSTRATING IMPROVEMENT IN RESPIRATORY STATUS WITH NO MORE WHEEZING AND MORE AIR EXCHANGE NOTED ON AUSCULTATION. HEART RATE DROPPED FROM 120-130'S TO 100-106. A TRIAL ALBUTEROL FROM THE NEPHRON COMPANY WAS ATTEMPTED. AGAIN NO FURTHER FOAMING OF THE MEDICATION SOLUTION OCCURRED. PT CONTINUED TO IMPROVE TO THE POINT THEY WERE EXTUBATED THE FOLLOWING DAY AT 14:40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-HEART LOW FLOW NEBULIZER NEBULIZER CAF WEST MED, INC. 100611 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization 1. LEVAQUIN, 2. CISATRICURIUM, 3. PROPOFOL,| NDC# 24208-347-20.| 4. HEPARIN, 5. FENTANYL, 6. DEXAMETHASONE.| ASTHMATICUS, LOT# 675581, EXP DATE 03/31/05,| ALBUTEROL INHALATION 0.5% 12MG EVERY HOUR. STATUS