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

Model Number 19189-001

Device Problems Kinked (1339); Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problems Bradycardia (1751); Cyanosis (1798)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It was originally reported that the ventilator patient circuit was kinked and would not allow airflow.Further details were later received regarding the reported problem.After the ventilator was placed on the patient for transport from the icu to mri, the ventilator had high pressure alarms.Upon arriving in mri, the patient became blue/purple from nose to top of head and the patient's heart rate began to decrease into the 40's.After the patient was removed from the ventilator and was manually ventilated for two minutes, the patient began to regain sats and the heart rate increased to the normal rate (as before).It was reported that the patient circuit tubing was crimped and crushed in one area.New tubing was placed and the patient then had the mri test completed.

Manufacturer Narrative

This mdr is being filed beyond the 30 day reporting timeline.

• Brand Name: LTV PATIENT CIRCUIT
• Type of Device: VENTILATOR, CONTINUOUS
• 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: 3967815
• MDR Text Key: 4748899
• Report Number: 2031702-2014-00179
• 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: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 19189-001
• Device Catalogue Number: 19189-001
• Device Lot Number: 0000655505
• Other Device ID Number: RMA 239133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention