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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL INC CONCHATERM NEPTUNE HEATED HUMIDIFIER; HUMIDIFIER SYSTEM
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TELEFLEX MEDICAL INC CONCHATERM NEPTUNE HEATED HUMIDIFIER; HUMIDIFIER SYSTEM Back to Search Results
Device Problems Device Alarm System (1012); Connection error (1116)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/06/2015
Event Type  Death  
Event Description
Ventilator set up on (b)(6) 2015 for gestation (b)(6) infant who was born in the car with twin enroute to the hospital.On (b)(6) 205 baby started to exhibit some respiratory distress.Baby reintubated mucus found on end of tube.After intubation attempted suction of baby and red blood noted.Baby died.Ultrasound of head also noted bilateral germinal matrix hemorrhages.Upon cleaning up of equipment rt noticed water bottle for active humidity circuit was not spike causing the edema to be dry.Therefore no humidity spike had gone in but not puncture one and water bottle.Temperature alarm did not sound.
 
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Brand Name
CONCHATERM NEPTUNE HEATED HUMIDIFIER
Type of Device
HUMIDIFIER SYSTEM
Manufacturer (Section D)
TELEFLEX MEDICAL INC
po box 12600
research triangle park NC 27709
MDR Report Key4726797
MDR Text Key5747647
Report Number4726797
Device Sequence Number1
Product Code BTT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Respiratory Therapist
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2015
Distributor Facility Aware Date03/06/2015
Event Location Hospital
Date Report to Manufacturer03/13/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/24/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age1 DA
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