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

Catalog Number DYNJAP9908

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2019

Event Type  Injury  

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 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.

• Type of Device: VYAIRE PEDIATRIC ANESTHESIA BREATHING CIRCUIT IN ANESTHESIA CIRCUIT PEDS KIT
• Manufacturer (Section D): VYAIRE; 26125 north riverwood blvd; mettawa IL 60045
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 8735518
• MDR Text Key: 149229866
• Report Number: 1417592-2019-00101
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10889942258079
• UDI-Public: 10889942258079
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAP9908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR