MAUDE Adverse Event Report: CAREFUSION ADAPTER VALVED TEE 22 MM OD/ID 30/CS; DRAIN, TEE (WATER TRAP)

Model Number 002061-A

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Therapist giving a nebulizer treatment (albuterol and saline) to a patient.  when the therapist removed the nebulizer from the "t" piece, the "t" caught on fire.  mr(b)(6) reports the "t" piece is the only part that appeared to be burned.  the carefusion sales rep spoke with the customer.  the following information was provided: "right now the hospital's biomed shop is keeping all parts for their investigation.The bipap was a respironics v60, it was a respironics dry circuit, hudson nebulizer, and they were using oxygen to drive the neb.The neb was inline at the end of the circuit by the mask.You can also contact the biomed department, (b)(6). (b)(6) is leading the investigation and can let us know when and if we can get the product returned. i will also send some pictures."   the therapist received burns to her fingers, (treated in the ed).No harm to the patient was reported.Additional information received from the risk manager: "right now the bipap unit and all of the supplies involved are in biomed and cannot be released at this point.I¿m sure you would be able to look at the item in biomed at some point in time.  i have the packaging in my office.  we would need paperwork in place on our end before that could happen.  i will let you know when we have that." the therapist received burns to her fingers, (treated in the ed).No harm to the patient was reported.

Manufacturer Narrative

(b)(4).The reporting facility has indicated that the device involved in the incident is not being released at this time.Pictures of the burned device have been provided to carefusion.If the device is not released by the end user, an evaluation will be performed using the pictures and information provided.A follow up will be sent if an evaluation is completed.

Manufacturer Narrative

(b)(4).The complaint device was eventually made available to carefusion from the reporting facility.An evaluation was performed into the customer¿s reported issue.Unfortunately, the customer did not provide any additional information to carefusion regarding the incident.The airlife valved tee adaptor is made of two components: (b)(4).It was observed that the end of the tee adaptor was burned and the plastic had melted, which was the blue k-resin material only.The clear cap did not appear to have burned at all.A review of the device history record (dhr) was performed for this lot of airlife valved tee adaptor (cm13l23).There were no issues identified during the manufacture of this lot that would have contributed to the reported issue.It was confirmed that the correct (b)(4) was used to manufacture this lot (cm13l23) of airlife valved tee adaptor.It was confirmed that the correct (b)(4) was used to manufacture this lot (cm13l23) of airlife valved tee adaptor.The certificate of analysis (coa) was reviewed for the lot of kr-03 (b)(4) used to manufacture cm13l23 of the airlife valved tee adaptor.The product exhibited the correct properties and conformed to all the specifications.(b)(4).The testing conformed to the required flammability standard.Http://site.Ul.Com/global/eng/pages/offerings/industries/chemicals/plastics/testing/flame/.A review of the carefusion complaint system was performed for this device over the last two years.There have been no other reported complaints received by carefusion for this same issue during this same time period.The reported issue will continue to be trended and evaluated by carefusion.This appears to be an isolated incident.Without additional information from the customer, the exact root cause could not be determined.

• Brand Name: ADAPTER VALVED TEE 22 MM OD/ID 30/CS
• Type of Device: DRAIN, TEE (WATER TRAP)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3979388
• MDR Text Key: 4892106
• Report Number: 2050001-2014-00017
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 002061-A
• Device Lot Number: CM13L23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• 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