MAUDE Adverse Event Report: CAREFUSION CIRCUIT ADULT 6FT PROT VENT 20/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number RT609-855

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/04/2014

Event Type  Injury  

Event Description

A patients home ht-50 started to high pressure, go into back up ventilation, and stopped reaching the pip after inline treatment was administered.The patient let the rcp know that he couldn't breathe.He was on the  carefusion circuit (rt609-855).There was a lot of rain out, and there was a lot of water in the exhalation valve.The rcp dried the exhalation valve and had the rn hand ventilate while the rcp recalibrated the vent several times and it would not pass.They then took a teleflex exhalation valve and changed the carefusion valve in the circuit and the calibration passed.Additional information received on 18feb from customer (b)(6): when asked where the exact placement of the svn was it, customer responded, ¿after the exhalation valve¿.This facility recently switched to this circuit over a month ago.

Manufacturer Narrative

(b)(4).Device evaluation anticipated but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Device evaluation: one (1) open sample was received for evaluation.The sample was inspected in accordance with our inspection procedure and the issue reported could not be confirmed at manufacturing plant.The valve was visually inspected and no discrepancies were observed.In addition, samples were sent to carefusion¿s research and design group.Based on their evaluation, it was concluded that airlife circuit rt609-855 frequently fails the calibration test on the newport medical ht50 and sometimes the ht70.A review of the documentation of internal manufacturing device history records could not be reviewed due to no lot number being reported.A two year data review was performed and it revealed that no similar issues were reported due to rain out on this product code.At this time, an alternative circuit is being created with a compatible exhalation valve.Carefusion will continue to monitor and trend this issue.

• Brand Name: CIRCUIT ADULT 6FT PROT VENT 20/CS
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3658652
• MDR Text Key: 15174730
• Report Number: 8030673-2014-00101
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: RT609-855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention