MAUDE Adverse Event Report: CAREFUSION 203, INC LTV PATIENT CIRCUIT; CIRCUIT, BREATHING

Model Number 15091-104

Device Problems Fire (1245); Melted (1385); Overheating of Device (1437); Smoking (1585)

Patient Problem Respiratory Distress (2045)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

The device is being held by the patient's family and will not be returned for evaluation at this time.

Event Description

It was reported that the patient's mother smelled smoke.She went to check on the patient and noticed that the heated wire was melting the circuit and then went on fire.The child was sent to the hospital and under went a bronchoscopy.It was also reported that the patient is now repeatedly being taken to hospital and "coughing up ash" per the patient's father.

• Brand Name: LTV PATIENT CIRCUIT
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer (Section G): CAREFUSION 203, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: jennifer huybrecht ; 7633988395
• MDR Report Key: 5069472
• MDR Text Key: 25482907
• Report Number: 2031702-2015-00206
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Respiratory Therapist
• Remedial Action: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 15091-104
• Device Catalogue Number: 15091-104
• Other Device ID Number: RMA 283927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/11/2015
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention