MAUDE Adverse Event Report: UNKNOWN INTERSCALENE NERVE CATHETER; ANESTHESIA CONDUCTION KIT

Patient Problems Chest Pain (1776); Dyspnea (1816); Nausea (1970); Loss of consciousness (2418); Confusion/ Disorientation (2553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2024

Event Type  Injury  

Event Description

Patient had shoulder reconstruction shoulder (uncomplicated) and a ropivacaine catheter (0.2% ropivacaine pump set at infusion rate of 8 cc/hr prior to discharge) placed the morning of presentation to ed.Later in the afternoon presented to the ed with difficulty breathing, chest pain, nausea, and episodes of confusion.Patient's mother turned the catheter down to half the rate without symptom resolution prior to ed admit.On ed arrival patient had episodes of unresponsiveness and concern for jerking motions (limited by arm brace) and episode resolved prior to antiseizure medication administration.Concern for local anesthetic systemic toxicity (last).Poison center recommended intralipid and after administration of intralipid bolus (100 ml of intralipid 20%), patient returned back to her neurologic baseline without any focal deficits.

• Brand Name: INTERSCALENE NERVE CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18799738
• MDR Text Key: 336564707
• Report Number: MW5152105
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: HYDROMORPHONE. THERAPY START & END DATE:
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White