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

Model Number RT509-852

Device Problems Hole In Material (1293); Melted (1385); Material Separation (1562); Torn Material (3024)

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

Event Date 08/03/2015

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

" the staff went to reposition the ventilator circuit and it ripped a hole in the expiratory limb.The hole was caused by the circuit melting the temp probe wire and it came apart when moved.We have seen this type of event before."report states sample is available.Medwatch number 4633010000-2015-8017.Customer also stated: 'leak detected quickly, patient manually ventilated with resuscitation bag and circuit changed.Part of the circuit was also covered by a cloth diaper where the posey tube holder was located.'.

Manufacturer Narrative

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 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.Two years of complaints were reviewed from (b)(6) 2013 - (b)(6) 2015 and no trend was observed in the last six months.At this time there is not any evidence that confirms that our operative personnel are contributing to this failure.During the manufacturing review no issues were found with the materials, equipment, environment, or design.Based on similar reports it was determined that the most probable cause could be related to a combination of several factors.These factors contributed to creating the excess heat concentrated in the small tube area.This softened or melted the tube wall.These factors are not recommended actions per the circuit¿s intended function.For example covering the circuit with blankets, or tying the limbs together.Another contributing factor could be that the wire retainer was not in its place at the end of the tube.This could occur at the point of use, and are external to the manufacturing facility.Therefore this is not under the control of the manufacturing facility.Our investigation revealed no issues.As a preventive action carefusion recommends following the product label for recommended uses.The cautions state 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.Ifu will be provided to the customer along with the investigation findings.

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; 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 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5100649
• MDR Text Key: 26947186
• Report Number: 8030673-2015-00140
• 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 faci
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: RT509-852
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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