MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ TEE ADAPTER WITH VALVE, 22MM O.D. X 22MM I.D. ISO CONNECTIONS; DRAIN, TEE (WATER TRAP)

Catalog Number 002061

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire had reached out to the customer to request the complaint device for further investigation.However, customer stated that device was not available.If any additional information becomes available a follow up emdr will be submitted.

Event Description

A customer reported to vyaire that the adapters were "popping off" and causing leaks in the circuit while connected to a patient.The t-piece was used to connect the patient to the ventilator.The massive leak caused the vent alarms to go off.When the respiratory therapist (rt) arrived, the disconnected spring piece was found on the patient's bed with the t-piece still connected between the ventilator and the patient.The patient experienced low saturations in the 50% range and difficulty breathing.The customer confirmed that there was no patient compromise as they were alerted to the leak and quickly re-connected valve.

Manufacturer Narrative

A sample or lot number was not returned; however, the manufacturer reviewed it's process based on the available information and determined the cause to be the manufacturer assembly process and operator error.Corrective actions were indicated.

• Brand Name: AIRLIFE¿ TEE ADAPTER WITH VALVE, 22MM O.D. X 22MM I.D. ISO CONNECTIONS
• Type of Device: DRAIN, TEE (WATER TRAP)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8797681
• MDR Text Key: 151274212
• Report Number: 3003799815-2019-00002
• Device Sequence Number: 1
• Product Code: BYH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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 Catalogue Number: 002061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1