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

Model Number AIRLIFE HME FILTER

Device Problems Disconnection (1171); Tidal Volume Fluctuations (1634); No Flow (2991); Pressure Problem (3012)

Patient Problems Bradycardia (1751); Distress (2329); Low Oxygen Saturation (2477); Cough (4457)

Event Date 05/18/2022

Event Type  Injury  

Event Description

Upon completion of fess procedure, pt reversed using sugammadex 200 mg after verifying 4/4 on tof (train-of-four) and sustained tetanus, attending anesthesiologist paged to notify "waking up".Pt remaining on ventilator, waiting for return of spontaneous ventilation.Pt suddenly coughed and sat up, eyes open, immediately popped off ventilator onto bag.Pt frantic and thrashing, reassured she was "waking up" and to try and "take a slow deep breath".Minimal etco2etc02 (end-tidal carbion dioxide) with very small tidal volumes, asked staff in room to help me keep pt on bed.Pt shaking head "no" to prompts to take slow deep breath.Attempted to hand ventilate pt, unable to maintain any pressure on bag.Checked for a circuit leak, none found, switched pt back to ventilator tv's on vent around 15 ml's and sp02(oxygen saturation) dropping.Ambu bag opened and circulator asked to hit code button on wall as well as page anesthesiologist again, surgeon present at bedside.Double clicked emergency code button on desktop as sp02 now dropping significantly.Several staff anesthesia staff members arrived to room, hr (heart rate) decreasing to 30's so decision made to do chest compressions.At most one round of compressions performed and epinephrine administered by different anesthesia staff member as well as albuterol puffs while ambu bag handed by crna to md at head of bed and upon disconnecting the circuit hme filter noted to be sticking out of the end of the reinforced ett (endotracheal tube).Hme filter withdrawn by hand by md and circuit re-connected.Immediately able to hand ventilate and sp02 slowly improving.Decision made to get chest x-ray, give lasix, keep pt intubated, place a-line (arterial line), and transfer to sicu in case of negative pressure pulmonary edema.Ett exchanged for a regular non-reinforced ett using cmac.Fda safety report id# (b)(4).

• Brand Name: AIRLIFE HME FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; irvine CA 92618
• MDR Report Key: 15078011
• MDR Text Key: 296411615
• Report Number: MW5111026
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE HME FILTER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White