BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE (INHALANT) 7 % NEBULIZER SOLUTION

    MDR report key: 19163649 · Received April 22, 2024

    Report

    Report Number
    MW5154078
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 18, 2024
    Manufacturer
    NEPHRON SC, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON 3/23 WITH ACUTE ON CHRONIC RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA. THE PATIENT WAS ADMITTED ON BROAD SPECTRUM ANTIBIOTICS, STEROIDS, AND SCHEDULED NEBULIZERS. ON 3/26 AT 2028, THE PATIENT RECEIVED 4 ML OF 7% SODIUM CHLORIDE SOLUTION FOR INHALATION. SHORTLY AFTER ADMINISTRATION, THE RESPIRATORY THERAPIST REPORTED THE PATIENT WAS "UNABLE TO BREATHE" WITH OXYGEN SATURATIONS DOWN TO 40% AND A HEART RATE IN THE 140S. THE PATIENT WAS THEN INTUBATED AND TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT). THE MEDICATION WAS NOT USED AGAIN, AND THE PATIENT WAS EXTUBATED ~1000 ON 3/27. COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)/ASTHMA WITH ACUTE EXACERBATION, PNEUMONIA. SIGNIFICANT PRIOR TO ADMISSION MEDICATIONS INCLUDE FUROSEMIDE, METOPROLOL, MIRTAZAPINE, ALBUTEROL, AS NEEDED OXYCODONE, AND TRELEGY ELLIPTA. THE PATIENT HAD NO SIGNIFICANT ALLERGIES AT THE TIME OF ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329942 SODIUM CHLORIDE (INHALANT) 7 % NEBULIZER SOLUTION NEBULIZER (DIRECT PATIENT INTERFACE) CAF NEPHRON SC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| L| H| R ACETAMINOPHEN.| ASPIRIN 81 MG CHEWABLE TABLET.| AZITHROMYCIN 250 MG TABLET.| CEFTRIAXONE 2G INJECTION.| FERROUS SULFATE 325 MG TABLET.| FLUOXETINE 40 MG CAPSULE.| FLUTICASONE-UMECLIDINIUM-VILANTEROL (TRELEGY ELLIPTA) 100-62.5-25 MCG/ACT INHALER.| FOLIC ACID 1 MG TABLET.| FUROSEMIDE 40 MG TABLET.| IPRATROPIUM-ALBUTEROL (DUONEB) 0.5-2.5 MG/3ML NEBULIZER SOLUTION. | OXYCODONE 5 MG TABLET.| PHILLIPS COLON HEALTH CAPSULE. | PREDNISONE 40 MG TABLET. | SUBQ HEPARIN 5000 UNITS.| THIAMINE 100 MG TABLET.