MAUDE Adverse Event Report: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT

Device Problem Obstruction of Flow (2423)

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

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, the root cause has not been determined yet vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the anesthesia machine gave a "check sample line" alarm, and the anesthesia provider could not proceed with the case until the issue was fixed.While troubleshooting the issue, it was discovered that the limb-o¿ single limb anesthesia breathing circuit had a knot in the gas sample line on the inside of the sample.Once the sample was replaced with a new product, the issue was fixed.No patient harm, but there was delay in patient care due to the circuit issue.

Manufacturer Narrative

Device evaluation: d9, g3, g6, h2, h3, h6 and h10.Result of investigation: some photographs and an open sample was evaluated.A visual inspection was performed and found that the gas line is kinked.Further investigation reveals that the root cause of the issue is manufacturing process, since it is not too clear how carry out assembly of sampling gas line in blue connector and it can cause a knot on it.Method to carry out assembly sampling gas line will be modified.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 11324185
• MDR Text Key: 232169033
• Report Number: 8030673-2021-00151
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AGN5241C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention