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U.S. Department of Health and Human Services

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

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MCKESSON MEDICAL SURGICAL INC. MCKESSON ANESTHESIA CIRCUIT ADULT COAXIAL CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
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).
 
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Brand NameMCKESSON ANESTHESIA CIRCUIT ADULT COAXIAL
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
MCKESSON MEDICAL SURGICAL INC.
9954 mayland dr
richmond VA 23233
MDR Report Key15301074
MDR Text Key298830098
Report NumberMW5111730
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 Voluntary
Reporter Occupation
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 Received08/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-C72
Device Lot NumberUNKNOWN-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 Treatment Data
Date Received: 08/25/2022 Patient Sequence Number: 1
Treatment
MCKESSON ADULT COAXIAL ANESTHESIA CIRCUIT
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