MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. ANES CIRCUIT, ADULT, 108 IN, EXPANDABLE, VITAL SIGNS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number AXXXX171

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Anesthesiologist applied the new ventilation circuit and found as the case began the circuit failed and was leaking.The incident was not an isolated event the leaks happened several times over a few months with new from the package circuited.We have emails from the manufacturing rep that shows there is was a manufacturing problem and damaged breathing circuits left the vyaire factory.Product number: axxxxx19 & axxxx171.Product description: anes circuit, adult, 108 in.Lot number: 0001196683, 0004004715, 0001201963, quantity: 3, vyaire complaint # has been issued.Manufacturer response for anes circuit, adult, 108 in., anesthesia breathing circuits product #'s axxxxx19 (per site reporter).Manufacture would send replacements as we identified the out of box failures.Manufacture opened a official complaint file #.Email from manufacturer: i wanted to touch base for a quick update.First off, thank you for your patience with the new breathing circuit.As of yesterday, i expedited the process.In terms of background, the sporadic leak issues experienced over the past few months were not isolated to your particular circuits, or expandable circuits in general.They were occurring in all of our styles on a random basis.As a company, we needed to isolate the source from a manufacturing basis.We believe it was a result of certain lots based upon personnel on the manufacturing lines.Hence, our ability to move forward was contingent upon this being completed.If the new circuits were instituted before, we still would have seen random occurrences of failed leak tests which would have caused greater frustration.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN, EXPANDABLE, VITAL SIGNS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 7861002
• MDR Text Key: 119788782
• Report Number: 7861002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018,08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AXXXX171
• Device Catalogue Number: AXXXXX19
• Device Lot Number: 0001196683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1