MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ BREATHING CIRCUIT COMPONENTS, HMEF 750/S WITH ELBOW, DISPOSABLE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number M1135230

Device Problem Moisture Damage (1405)

Patient Problem Electrolyte Imbalance (2196)

Event Date 06/24/2019

Event Type  malfunction  

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

It was reported to vyaire that the water droplets on the hmef, caused a problem of rising etco2 in patient due to condensation.It was further explained that only one (1) patient had experienced this issue.About 1 hour after the start of the anesthesiology department, the baseline of etco2 waveform rose immediately after replacing soda lime.The level of rising etco2 was unknown.It was determined by the end user customer that the rising of etco2 was due to condensation since after soda-lime replacement, the circuit check did not improve even after passing through, and when looking at the hmef, there was significant condensation of the hmef (the filter was flooded with water).After replacing the hmef, the baseline of the etco2 returned to normal.The hmef was securely replaced before anesthetic administration to the patient.The product was stored in the room temperature and opened immediately before usage.The patient's temperature was 36.8 ° c and no significant hyperthermia was noted.The room temperature was about 24 ° c, which was not an environment that exhibited significant condensation due to the temperature difference.The patient was in a supine position and the tube was not contaminated with cough or sputum during intubation.In addition, the flow rate during anesthesia was 3 l / min, not low flow rate.There was patient involvement; however, no patient injury or harm was reported.No medical intervention was needed.

Manufacturer Narrative

A cause was not determined, since sample was not returned for evaluation; due diligence was completed.However, a device history review was completed and no issues were identified during the review that may have contributed to the reported issue.

• Brand Name: VITAL SIGNS¿ BREATHING CIRCUIT COMPONENTS, HMEF 750/S WITH ELBOW, DISPOSABLE
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8797589
• MDR Text Key: 202085896
• Report Number: 3004050971-2019-00001
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K031653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M1135230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other