MAUDE Adverse Event Report:; DBD-ANESTHESIA CIRCUIT ADULT-LF

Catalog Number DYNJAA6596

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the inner tubing of the anesthesia circuit was found to be "knotted up" and that a "low cardiac output" message was experienced during an unspecified patient procedure.Reportedly, the procedural staff believed the patient was coding even though the patient was stable.Despite multiple good faith attempts the customer was unwilling or unable to provide additional information to the manufacturer.No adverse patient impact, medical intervention, or follow-up care was originally reported to the manufacturer.No sample has been returned to the manufacturer for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the inner tubing of the anesthesia circuit was found to be "knotted up.".

Manufacturer Narrative

A sample was returned to the manufacturer and evaluation has been completed.Inspection of the returned sample confirmed the reported product problem/issue.The gas sampling line of the anesthesia circuit was noted to be kinked at the filter end near the luer connection.A root cause was unable to be determined at this time.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: DBD-ANESTHESIA CIRCUIT ADULT-LF
• MDR Report Key: 11589137
• MDR Text Key: 244255850
• Report Number: 1417592-2021-00052
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAA6596
• Device Lot Number: 20DBH516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other