MAUDE Adverse Event Report: CAREFUSION, INC CIRCUIT PED 5FT DUAL-HTD 20/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number RT509-852

Device Problems Melted (1385); Use of Device Problem (1670); Material Integrity Problem (2978)

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

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission - customer advocacy has reached out to customer to provide sample for the investigation.Ups label was provided to the customer.At this time we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

Medwatch (b)(4) was received.A fischer and paykel product code mr850 was listed in the medwatch.This medwatch has been forwarded to fischer and paykel.The customer reported the following.In the middle of the ventilation circuit, towards the end of the heated limb, the heated wire melted an approximate 2 inch hole through the circuit.Circuit was being used on patient at time of failure.Customer reported no harm to patient.The nurse noted that the corner of the pillow was on top of the ventilator tubing.As a result, the tubing melted in that spot.Respiratory therapist was contacted immediately, patient was bagged, and the ventilator tubing was changed out."we realize that items are not supposed to be on top of this tubing, but we would like to see the plastic be a little more durable because when a patient is in bed, there are a lot of items that come in contact with the tubing.Staff monitor the tubing closely and we know that nothing should cover it.It just makes sense to have a more durable product that can withhold some contact which is inevitable to happen.".

Manufacturer Narrative

(b)(4).It was confirmed by the end-user that the circuit was covered by a pillow per email 02/16/2016.Device evaluation summary.One open sample (circuit) was returned and per visual inspection the melted tubing was confirmed on the expiratory limb of the circuit.Sample was functionally (resistance) tested, and no issues were found with the reading.They were found within spec; unfortunately without a lot number available it is not possible to review the batch history record to search for any extraordinary event that could contribute to the defect reported.At this time there is not any evidence that confirms that our operative personnel are contributing to this failure.During the manufacturing review it was observed that product is 100% tested by resistance function.No issues were found with the materials.It is not considered that equipment is related to the failure mode.No issues were found with the design.Root cause could not be determined, however it was determined that the most probable cause could be related to a combination of several factors that contribute to creating excess heat concentrated in a small tube area.Resulting in the softening or melting of the tube wall.These factors are not recommended actions per the circuit¿s intended function.For example a circuit covered with blankets, limbs tied together, or the wire retainer was not in its place at the end of the tube.This would occur at the point of use, and are external to the manufacturing facility, therefore not under its control.As a preventive action, carefusion recommends following the product label for recommended uses.The product label states the following: minimum flow rate o3.0 lpm o1.5 lpm.Do not use this circuit where gas temperature at the outlet of the humidifier exceeds 68 degrees celsius.Do not use the heater circuit-without gas flow.Do not place material on or around the heated wire tubing.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: CIRCUIT PED 5FT DUAL-HTD 20/CS
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION CORP DBA PRODUCTOS UROLOGOS DE MEXICO S; cerrada via de la produccion #; parque industrial mexicali iii; mexicali b.c. 21397 ; MX 21397
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5474409
• MDR Text Key: 39841818
• Report Number: 8030673-2016-00157
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT509-852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention