FDA Adverse Event Injury Summary report: N

CLEAR THERM MINI FILTER/HME

MDR report key: 5303377 · Received December 12, 2015

Report

Report Number
MW5058538
Event Type
Injury
Date Received
December 12, 2015
Report Date
December 12, 2015
Manufacturer
INTERSURGICAL INC
Product Code
BTT
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
2

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
821496 CLEAR THERM MINI FILTER/HME HUMIDIFIER USED WITH ANESTHESIA BTT INTERSURGICAL INC

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention