MAUDE Adverse Event Report: CAREFUSION HME ADULT HEPA FILTERED 20/CS; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number 003007-A

Device Problem Deflation Problem (1149)

Patient Problem Cardiac Arrest (1762)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

Customer informed sales rep that patient arrested while attached to item: 003007, (on ventilator).  customer informed sales rep that they have experienced issues with this item.Patient survived.Meeting held today regarding this incident.Sample is being held by facilities "risk management" department.Carefusion spoke with manager (b)(6) regarding the complaint.Per (b)(6), he reported that the staff feel that they have to change hme device frequently since they started using it.He reported that yesterday "a resident came into the patient's room and saw that the patient's wave forms were non-existant and then the patient coded.Once they revived, the patient they changed the hme and the patient remained on the vent without injury"."after the code, the staff brought the hme that had been on the circuit to his office.They tested it by placing it on a resuscitation bag.They noticed it was difficult to deflate the bag without increased force." if at all possible, he will send the sample to carefusion once cleared by the hospital.For now, they will be using a different hme.They chose this particular model because they do not use heaters or humidifiers and want a hepa filter.He is unaware of what circuit was being used and reported that the vents that are used at the facility are the drager xl and the evita 2.He did have a meeting with (b)(4) yesterday regarding the product concerns they have.He did show her how they tested the hme using a resuscitation bag.He did question if they are possibly using the product wrong or for too long of a period.

Manufacturer Narrative

(b)(4).To date, the complaint device has not been returned by the user facility for evaluation.If received, the device will be sent to the manufacturing site for evaluation and a follow up will be sent.

Manufacturer Narrative

(b)(4).The customer did not return the actual complaint product to carefusion for evaluation.As a result, an exact root cause could not be determined.However, an investigation was completed by the manufacturer based upon the customer's reported issue.Retention samples from this lot were also tested.A review of the device history record (dhr) was performed for this lot (sj0713011).There were no issues identified during the manufacture of this lot that would have contributed to the reported issue.Three retention samples were inspected from this lot (sj0713011).An appearance inspection and air resistance test passed.Based upon the reported issue, 3 hmes (2 from lot sj0713011 and 1 from lot sj1112006) from retention samples were tested.An air resistance test was performed (flow of 1.0l/sec) and the initial resistance value was recorded.The results confirmed that storage time has no effect on the hme and the resistance values were still within specification.A moisture test, which imitates a person¿s breathing, was performed.An initial resistance value was then recorded.The resistance values were still within specification after moisture testing, which imitates normal breathing from a patient.The customer indicated that their facility is using hepa filtered hmes on all patients as standard operating procedures.Without knowing the exact condition of the patients, an exact root cause could not be determined.It appears that the hepa filtered hme may not be the best hme option for every patients.It is possible that these particular patients were producing too much phlegm.The instructions for use (ifu) for this product ((b)(4)) indicates: ¿replace every 24 hours or more frequently, as required, to avoid increased resistance due to accumulation of secretions¿.Carefusion recommends changing as needed because every patient situation is not the same, such as the amount of secretions each patient produces.A review of the carefusion complaint system was performed for this device over the last 12 months ((b)(6) 2013 through (b)(6) 2014).There have been no other customer reported complaints of any kind for this device during this time period.The reported issue will continue to be trended and evaluated by carefusion.

• Brand Name: HME ADULT HEPA FILTERED 20/CS
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• 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: 3833582
• MDR Text Key: 4498238
• Report Number: 2050001-2014-00016
• Device Sequence Number: 1
• Product Code: BYD
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2014

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: 003007-A
• Device Lot Number: SJ0713011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 05/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• 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
• Patient Outcome(s): Required Intervention