MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE HME FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number AIRLIFE HME FILTER

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that a patient experienced an adverse event while connected to sku: 3021 product: bypass hme, filtered.The customer said that the patient sustained tetanus upon completing a functional endoscopic sinus surgery (fess).The attending anesthesiologist paged his team to notify them of the "waking up" patient.The patient remained on the ventilator, waiting to return to spontaneous ventilation.The patient suddenly woke up, and the team immediately removed the patient from the ventilator and provided positive pressure ventilation via a bag-mask valve.Minimal etco2 was noted with small tidal volumes.The clinicians stated that they could not maintain any pressure from the bag.The clinicians checked for a circuit leak, but none were found, and the patient was placed back on the ventilator.The patient's saturation began to drop, and the heart rate decreased to the 30's.The staff decided to begin chest compressions and give the patient the necessary drugs to raise all vital signs.The physician noticed that the circuit hme filter was sticking out of the end of the reinforced endotracheal tube.The hme filter was withdrawn, the circuit was reconnected, and the team could immediately ventilate the patient.The patient's vital signs began to improve slowly.At this time, it is unknown if the patient experienced any further harm or injury.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, 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.

• Brand Name: AIRLIFE HME FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): AMSINO MEDICAL (SHANGHAI) CO. LTD; building no. 1-3, lane 355 hua; songjiang export processing; shanghai, 20161 3; CH 201613
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15307519
• MDR Text Key: 298763006
• Report Number: 3013421741-2022-00020
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE HME FILTER
• Device Catalogue Number: 003021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention