MAUDE Adverse Event Report: INTERSURGICAL INC CLEAR THERM MINI FILTER/HME; HUMIDIFIER USED WITH ANESTHESIA

Device Problem Occlusion Within Device (1423)

Patient Problems Obstruction/Occlusion (2422); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

Would like to bring to your attention two airway incidents that were experienced with using the hme (humidifier) intersurgical inc clear therm mini filter/hme.One incident that was noticed was a sudden near complete airway obstruction with failure to deliver adequate tidal volume, and difficulty providing manual positive pressure ventilation.The first occurrence was about a year ago or so, during a cath lab procedure on an infant with single ventricle with no respiratory issues prior to any intervention.There was failure to deliver adequate tidal volume and airway resistance alarm followed by desats.Anesthesiologist identified the malfunctioning piece by eliminating it out the circuit and blowing through it confirming the obstruction.No harm done to the pt as this was caught early and resolved immediately upon removal of the hme (smaller size).Last week we had another similar incident in an airway case where this hme (larger size) was being used, once again airway compliance issues were resolved after eliminating the hme out the circuit and testing it confirmed the source of obstruction.Once this info was shared with the group of anesthesiologist it was said to have occurred on at least 2 prior occasions causing that practitioner to stop using equipment.

• Brand Name: CLEAR THERM MINI FILTER/HME
• Type of Device: HUMIDIFIER USED WITH ANESTHESIA
• Manufacturer (Section D): INTERSURGICAL INC
• MDR Report Key: 5303377
• MDR Text Key: 33732384
• Report Number: MW5058538
• Device Sequence Number: 1
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention