MAUDE Adverse Event Report: CAREFUSION HUMIDIFIER

Lot Number TL 0514018

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problems Bradycardia (1751); Dyspnea (1816); Decreased Respiratory Rate (2485)

Event Date 02/16/2014

Event Type  Injury  

Event Description

Reporter said that her baby was born three months preterm and was on 2 liters of oxygen installed by a respiratory therapist.It worked well for some time.On (b)(6) 2015, the sterile water for the humidifier ran into the baby's nostrils and lungs.This was noticed when the apnea monitor alarm went off.The baby choked and had low heart and breathing rate.The baby was rushed to the hosp where he stayed overnight.About 200 mls of water was suctioned from his lungs.Patient was discharged from the hosp.The device was replaced by her hcp which is equipped with a separate device to trap water from getting into the nostrils.Currently the baby is stable.

• Brand Name: HUMIDIFIER
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 4541647
• MDR Text Key: 5508482
• Report Number: MW5040883
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Lot Number: TL 0514018
• Other Device ID Number: NPN 8002
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 5