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

Model Number 10822X10

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/07/2015

Event Type  Injury  

Event Description

It was reported that a piece of the patient circuit tubing which was connected to the ventilator was broken.The patient was manually ventilated, the patient circuit was replaced, and the patient was placed back on the ventilator.The patient has been discharged from the hospital.

Manufacturer Narrative

The actual patient circuit that was involved in the reported event has not been returned to the manufacturer for evaluation.The customer sent us photos of the patient circuit and we were able to verify that the patient circuit sense line had broken off of the patient wye.

• 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: 4835819
• MDR Text Key: 5911309
• Report Number: 2031702-2015-00108
• 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: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10822X10
• Device Catalogue Number: 10822X10
• Device Lot Number: 008458730000869
• Other Device ID Number: RMA 274845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/10/2015
• 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): Required Intervention
• Patient Age: 82 YR