MAUDE Adverse Event Report: CAREFUSION CIRCUIT NEO 4FT HTD W/18IN REMOTE 30/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number RT4851-18

Device Problems Air Leak (1008); Melted (1385)

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

Event Date 05/02/2014

Event Type  malfunction  

Event Description

Customer reported: expiratory limb of circuit melted, causing leak in circuit, (using with mr850 heater) customer is in possession of the sample to be returned.Additional information received from ((b)(6)): the circuit was in use for 10 days when the melting of the circuit occurred.The rn noticed hissing sound on the circuit and notified the rt.The rt felt air was coming out of the melted area on the circuit.Lot number not known.

Manufacturer Narrative

(b)(4).Device evaluation anticipated but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Results of investigation: one open sample (circuit) was returned for evaluation.Per visual inspection, the melted tubing was confirmed on the expiratory limb of the circuit.Sample was functionally (resistance) tested and no issues were observed, reading was 26.7 ohms from the allowed specification 24.0-27.0 ohms.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 there is not any evidence that confirms that carefusion¿s operative personnel is contributing to this condition.During the manufacturing review, it was observed that product is 100% tested by resistance function, and no assembly errors were observed during current production.In addition, no issues were found with the materials or design.Based on the investigation, the most probable cause for the issue reported could not be determined.A capa was opened to conclude this investigation.Our investigation review revealed no issues.As a preventive action, carefusion recommends following the product label for recommended uses.The product label states the following: humidifier: mr850 with wire adapter 900mr800, minimum flow rate 3.0 lpm.Humidifier: mr700, mr720, mr730, hc500 with wire adapter 900mr900, minimum flow rate 1.5lpm.Carefusion will continue to monitor and trend this report.

• Brand Name: CIRCUIT NEO 4FT HTD W/18IN REMOTE 30/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: 3840867
• MDR Text Key: 4687446
• Report Number: 8030673-2014-00116
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: RT4851-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2014
• 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