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

Model Number 10822X10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by the customer that the last five or six of the patient circuits have had the same "dangerous" defect.In the three-tube bundle of sense lines and exh-valve control line, the friction fit control line has been shorter than the two screw-on sense lines, thereby depriving it of the strain relief that it needs in order to stay connected.It was further reported that they have had several incidents of "pull-off" which instantly stops breathing.It is unknown if the ventilator had an audible alarm or if there was any patient harm.

Manufacturer Narrative

The patient circuits have not been returned for evaluation.Multiple attempts have been made to obtain further information from the customer and the customer has not responded.

• 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: 4752470
• MDR Text Key: 5826649
• Report Number: 2031702-2015-00075
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10822X10
• Device Catalogue Number: 10822X10
• Device Lot Number: 144613
• Other Device ID Number: RMA 270727
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 04/06/2015
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1