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

Patient Problem No Code Available (3191)

Event Date 02/20/2014

Event Type  Injury  

Event Description

Patient was on the rt609-855 using the newport ht70+.  upon arrival from a patient procedure, the high pressure alarm kept triggering, the rcp conducted an assessment  of the circuit and decided to disconnect  the patient for patient safety. while the patient was attended to by the nurse, the rcp determined that there was no flow coming out of the circuit.  the rcp attempted to recalibrate the ventilator with the circuit and it failed calibration.  the rcp took another rt609-855 circuit setup and attempted calibration and once again it failed.  we then changed the exhalation valve on the rt 609-855 circuit, it was at that time that the calibration passed.Patient placed back on the ventilator.Sample of the valve is available.

Manufacturer Narrative

(b)(4).Only the sample of the exhalation valve was sent in for evaluation.The sample was sent to carefusion's research and design department for evaluation.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Device evaluation: one sample was received for evaluation at carefusion¿s research and design group in (b)(4).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.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: 3668005
• MDR Text Key: 4344464
• Report Number: 8030673-2014-00104
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• 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: 02/28/2014
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention