MAUDE Adverse Event Report: WILMARC, LLC WILMARC ADULT COAXIAL ANESTHESIA CIRCUIT KIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Catalog Number AC72W3MY

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Hypoxia (1918)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

Wilmarc adult coaxial anesthesia circuit kits found to have very loose connection at the site of the filters.Became disconnected during a case and not discovered until the patient became hypoxic.After discovery the patient was fine.No injury.

• Brand Name: WILMARC ADULT COAXIAL ANESTHESIA CIRCUIT KIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): WILMARC, LLC; 3420 precision dr.; fort collins CO 80528
• MDR Report Key: 14564365
• MDR Text Key: 293102971
• Report Number: 14564365
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2022,05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AC72W3MY
• Device Lot Number: 1318565
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2022
• Date Report to Manufacturer: 06/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Male