MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number AIRLIFE¿ HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE

Device Problem Leak/Splash (1354)

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

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.However, the customer stated that the device is available for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that two airlife hmef 1000/s with flexible tube and double swivel elbow, disposable leaks on 2 anesthesia circuits (180ml).The issue occurred during patient-use and the defective filters were replaced.The customer also indicated that due to the issue, patient management was delayed.No patient harm was noted.

Manufacturer Narrative

Result of investigation: according to the photo investigation, the leakage was from the 22mm double swivel elbow and adapter.The retain sample of lot 0207771 was tested.And failed the leak test.The root cause is determined to be presence of o-ring and improper operator error that worker did not fully inspect with proper rotation speed.

• Brand Name: AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10713358
• MDR Text Key: 212351132
• Report Number: 3004050971-2020-00008
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 10190752139848
• UDI-Public: (01)10190752139848(10)0207771
• Combination Product (y/n): N
• PMA/PMN Number: K964204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: AIRLIFE¿ HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE
• Device Catalogue Number: 557019500
• Device Lot Number: 0207771
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 04/18/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention