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 Air Leak (1008); Hole In Material (1293); Melted (1385); Tidal Volume Fluctuations (1634)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/07/2014

Event Type  Injury  

Event Description

Customer reported via email:   during bedside rcps initial patient and ventilator assessment, rcp noticed abnormally low exhaled tidal volumes.  after quick trouble-shooting, rcp discovered a section of the expiratory limb on the ventilator circuit to be melted with small holes where the air was leaking out.  fisher paykel  heater was set at 37 degrees.  no audible or visual alarms were activated on the ventilator nor the heater.  the circuits were not touching, and no cloth material was surrounding the circuits.

Manufacturer Narrative

(b)(4).Unfortunately, no sample was received for evaluation.A review of the documentation of internal manufacturing device history records could not be reviewed due to no lot number being reported.During the manufacturing process review, it was observed that product is 100% tested by resistance function.No assembly errors were observed during current production.In addition, no issues were found with the materials or design; the materials used for this catalog are validated.Based on the investigation, the most probable cause for the issue reported could not be determined without a sample.As a preventive action, carefusion recommends following the product label for recommended uses.The product label states the following applications: humidifier wire adapter minimum flow rate mr850 900mr805 3.0lpm mr700, mr720, 900mr900 1.5 lpm mr730, hc500 cautions: 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.Carefusion will continue to monitor and trend this issue.

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: 4150215
• MDR Text Key: 4768455
• Report Number: 8030673-2014-00130
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: RT509-852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• 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