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 Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

Customer reported:  i have picked up 2 more vent circuits rt509-852 from one of the patients.  these two circuits melted thru in the last 10 days.  this is from the (b)(6) family who are planning to visit in (b)(6).  they seem to have more problems than anyone else.  they had a third circuit that was discarded.  there was no patient harm and the circuit was replaced with another rt509-852 circuit.  i don't have info on the lot number at this time.(b)(4) were opened to capture the other two incidents.

Manufacturer Narrative

(b)(4).Sample was discarded and not available for investigation.Upon carefusion's investigation, a follow up medwatch will be submitted.

• 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 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3563134
• MDR Text Key: 17155412
• Report Number: 8030673-2014-00084
• 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,User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: RT509-852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1