MAUDE Adverse Event Report: VYAIRE; VYAIRE PEDIATRIC ANESTHESIA BREATHING CIRCUIT IN ANESTHESIA CIRCUIT PEDS KIT

Catalog Number	DYNJAP9908
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that, during patient transport, the anesthesiologist was unable to put the cap on the valve of the vyaire pediatric anesthesia breathing circuit resulting in the patient experiencing desaturation (unknown value).The end-user facility was transporting a (b)(6) year old patient and reportedly had to place a finger over the valve, to provide a closed circuit, without further incident.No additional intervention was indicated.This device is a component in a custom pediatric anesthesia kit and the device is manufactured by vyaire.As the manufacturer of the device, vyaire will conduct an investigation and make the determination if any corrective action is indicated.No additional information is available at this time.Vyaire has been notified of the reported incident and the sample that was returned to medline has been forwarded to vyaire for evaluation.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 anesthesiologist was unable to put the cap on the valve during patient transport resulting in the patient experiencing desaturation.

• Common Device Name: VYAIRE PEDIATRIC ANESTHESIA BREATHING CIRCUIT IN ANESTHESIA CIRCUIT PEDS KIT
• Manufacturer (Section D): VYAIRE; 26125 north riverwood blvd; mettawa IL 60045
• MDR Report Key: 8735518
• Report Number: 1417592-2019-00101
• Device Sequence Number: 1845762
• Product Code: CAI
• UDI-Device Identifier: 10889942258079
• UDI-Public: 10889942258079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: DYNJAP9908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/26/2019
• 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: 2 YR