MAUDE Adverse Event Report: MCKESSON MEDICAL SURGICAL INC. MCKESSON ANESTHESIA CIRCUIT ADULT COAXIAL; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 16-C72

Device Problems Tidal Volume Fluctuations (1634); Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Hypoventilation (1916); Irritability (2421)

Event Date 08/23/2022

Event Type  Injury  

Event Description

A 18 year old with severe autism and behavioral issues having general anesthesia for dental surgery as first case of day.A mckesson adult coaxial anesthesia circuit was used.The circuit and anesthesia delivery system passed the pre-use mindray anesthesia machine self-check.The patient underwent inhalation induction of anesthesia after oral sedative/ anxiolytic premedication.With mask placement the patient became agitated and despite 50% nitrous oxide and 8% sevoflurane, anesthetic depth did not increase as the inspired sevoflurane concentration did not rise above 3% and the exhaled sevoflurane concentration was at 1.5 % despite 8% at dial.No leak or disconnect in the circuit was noted.Intramuscular ketamine was administered which allowed iv insertion and administration of iv induction agents.The patient was intubated however ventilation resulted in small tidal volumes and abnormal anesthesia bag ventilation.The patient was re-intubated with same outcome despite tracheal intubation confirmed during laryngoscopy.A mapleson bag was attached to tracheal tube with normal ventilation.The anesthesia circuit was replaced with a new one and with normal ventilation.Upon inspection, the distal end of the coaxial circuit had an obstruction in the internal (inspiratory) limb and when the outer limb was cut open, the internal limb was found to be twisted and greater than 75% occluded.The patient did have a prolonged induction of anesthesia with obstructed attempt to inspire and required im ketamine that prolonged his return to full alertness and recovery from anesthesia.While the patient had no hypoxemia or long term sequelae due to early recognition of the defect by experienced practitioners, this manufacturing defect could have caused profound hypoxemia, inspiratory obstruction causing post obstructive pulmonary edema or anesthesia machine failure.Fda safety report id# (b)(4).

• Brand Name: MCKESSON ANESTHESIA CIRCUIT ADULT COAXIAL
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MCKESSON MEDICAL SURGICAL INC.; 9954 mayland dr; richmond VA 23233
• MDR Report Key: 15301074
• MDR Text Key: 298830098
• Report Number: MW5111730
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-C72
• Device Lot Number: UNKNOWN-PACKAGING NOT PRESENT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCKESSON ADULT COAXIAL ANESTHESIA CIRCUIT
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 39 KG