MAUDE Adverse Event Report: CAREFUSION NEBULIZER HEATER 1/CS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 2M8021

Device Problem Sparking (2595)

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

Event Date 02/01/2015

Event Type  Injury  

Event Description

Information received by carefusion via a medwatch report "event desc: crt was changing the water bottle connected to the nebulizer heater.Heater sparked at electrical connection on the heater.Heater immediately removed from service and sent to biomed for disposal.No repair on these heaters.Crt and patient not harmed." the patient was a (b)(6) year old female child.

Manufacturer Narrative

(b)(4).Additional information was received from the customer confirming that the reported issue did not occur during a procedure.In addition, it was confirmed that there was no patient or healthcare professional injured as a result of the reported issue, nor was there any medical or surgical intervention required.The customer indicated that it was unknown what caused the spark, but confirmed that there had been no water spilled on the heater.The customer confirmed that all of their equipment, including the nebulizer heaters, goes through a preventative maintenance inspection.The customer confirmed that the heater is no longer available for return to carefusion for investigation.Since the actual heater is no longer available, an evaluation of the device could not be performed by carefusion.Investigation into this serial number determined that the heater was manufactured on 01/04/2008.It was also determined that the heater was purchased on 03/07/2008, and may have been in use for 7 years.It was confirmed that the warranty of this heater expired 03/08/2009.The device history record (dhr) was reviewed for this lot number.The dhr showed that this lot passed all initial testing (hi voltage, power, current leakage, temperature, resistance, and burn in).Without the actual complaint device, the exact root cause could not be determined.A review of the carefusion complaint system was performed for this product ((b)(4)) over the last 24 months.There have been no other reported complaints for a spark/fire/flame during this time period.The reported issue will continue to be trended and evaluated by carefusion.This appears to be an isolated occurrence.

Manufacturer Narrative

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

• Brand Name: NEBULIZER HEATER 1/CS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): VINCENT MEDICAL; 45-46 shabu industrial zone; qiao long district; guangdong ; CH
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4707410
• MDR Text Key: 5662460
• Report Number: 2050001-2015-00023
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• 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: 2M8021
• Device Lot Number: 0802010230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/20/2015
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR