MAUDE Adverse Event Report: NEPHRON SC, INC. SODIUM CHLORIDE (INHALANT) 7 % NEBULIZER SOLUTION; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problems Dyspnea (1816); Hypoxia (1918); Tachycardia (2095); Low Oxygen Saturation (2477)

Event Date 03/26/2024

Event Type  Injury  

Event Description

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.

• Brand Name: SODIUM CHLORIDE (INHALANT) 7 % NEBULIZER SOLUTION
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): NEPHRON SC, INC.
• MDR Report Key: 19163649
• MDR Text Key: 340965866
• Report Number: MW5154078
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Other; Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White