MAUDE Adverse Event Report: WESTMED, INC.; ANESTHESIA CIRCUIT

Catalog Number S6320P

Device Problems Partial Blockage (1065); Device Sensing Problem (2917); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 07/29/2015

Event Type  malfunction  

Event Description

Critically ill adolescent was transported to the operating room for urgent surgery by the anesthesia team, was fully monitored, and underwent anesthetic induction with endotracheal intubation.At a point early in the case, a new component was added to the plastic anesthetic breathing circuit by the anesthesia team, which was noted to prevent any analysis of breathed gases (fresh gas o2 and air, volatile agent, end tidal carbon dioxide).Quickly, the added component was removed and replaced, and gas analysis resumed using the previous component pieces.The device was quickly found to have a manufacturer defect.A blockage of the sample line was found.It appeared a drop of hardened manufacturer glue occluded the small lumen which in this case was cone shaped internally rather than the normal cylindrical shape.The patient's condition did not change during the event, but was a high risk patient for decompensation, and the gas analyzer is an essential piece of monitoring the patient safely in this case.Interruption was brief, and no harm came but it did reach the patient.

• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 south nogales hwy; tucson, AZ 85706
• MDR Report Key: 5079824
• MDR Text Key: 25910065
• Report Number: 5079824
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: S6320P
• Device Lot Number: 04272015T10
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 52