MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANESTHESIA CIRCUIT PEDS UNI-LF

Catalog Number	DYNJAPF6057A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during the start of the anesthetic, while the patient was undergoing an esophagogastroduodenoscopy (egd) and a colonoscopy procedure, the inspiration and exploratory channels were not able to communicate due to the green inspiration limb becoming unbonded at one end resulting in patient rebreathing which caused a transient increase in co2 levels.The patient was ventilated with an ambu bag and switched to a new circuit without further incident.The customer reported that there was a one hour delay in the procedure to resolve the issue; however the procedure was able to be completed without further impact or follow up treatment required.General anesthesia was used and the patient was under anesthesia longer than expected.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident or the additional anesthesia.The sample was returned to the manufacturer for evaluation and the root cause was determined to be due to an improperly bonded circuit.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the anesthesia circuit was not bonded leading to inaccurate co2 levels during a procedure.

• Common Device Name: ANESTHESIA CIRCUIT PEDS UNI-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9174788
• Report Number: 1417592-2019-00174
• Device Sequence Number: 480089
• Product Code: CAI
• UDI-Device Identifier: 10889942976577
• UDI-Public: 10889942976577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAPF6057A
• Device Lot Number: 19GB1659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Weight: 40