MAUDE Adverse Event Report: CAREFUSION INC. VITAL SIGNS ANESTHESIA BREATHING CIRCUIT; NEONATAL ANESTHESIA CIRCUIT

Catalog Number 1552017

Device Problems Deflation Problem (1149); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Date 02/19/2018

Event Type  malfunction  

Event Description

During a direct laryngoscopy and bronchoscopy the anesthesiologist opted to have the patient spontaneously breathing throughout the procedure.It quickly became evident that the infant was struggling to breathe.Staff quickly began to trouble shoot the situation.The anesthesia gas machine had passed all preliminary tests leading staff to believe the patient was experiencing bronchospasms.The infant was deteriorating and staff gave epinephrine.Surgical staff was about to begin chest compressions when the anesthesiologist realized the bag attached to the anesthesia gas machine remained inflated despite the mask being off of the patient.The surgical staff realized that a small piece of plastic was stuck between the filter and the patient mask preventing airflow to the patient.The small circular piece of plastic was removed and the procedure was completed using the same circuit without incident or harm to the patient.Clinical engineering examined the small piece of plastic and suspects it to be part of the bag the circuit or the face mask came in.Clinical engineering will be conducting further material testing to determine the origin of the plastic piece.Manufacturer response for neonatal anesthesia circuit, vital signs anesthesia breathing circuit (per site reporter): the manufacturer is confirming if this piece of plastic might have been a remnant of the manufacturing process.They have opened a complaint file for investigation.Unfortunately the circuit was not saved and the lot cannot be identified.

• Brand Name: VITAL SIGNS ANESTHESIA BREATHING CIRCUIT
• Type of Device: NEONATAL ANESTHESIA CIRCUIT
• Manufacturer (Section D): CAREFUSION INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7305780
• MDR Text Key: 101299690
• Report Number: 7305780
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1552017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1