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U.S. Department of Health and Human Services

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

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CAREFUSION INC. VITAL SIGNS ANESTHESIA BREATHING CIRCUIT NEONATAL ANESTHESIA CIRCUIT Back to Search Results
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.
 
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Brand NameVITAL SIGNS ANESTHESIA BREATHING CIRCUIT
Type of DeviceNEONATAL ANESTHESIA CIRCUIT
Manufacturer (Section D)
CAREFUSION INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key7305780
MDR Text Key101299690
Report Number7305780
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1552017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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