MAUDE Adverse Event Report: CAREFUSION, INC HUMIDIFIER KIT 500ML; RESPIR THER HUMID CONTAIN STERILE WATER FOR USP

Model Number 002620

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer is returning the complaint device for evaluation.If received, the complaint device will be forwarded to the manufacturing site for evaluation.A follow up will be submitted if the complaint device is returned and an evaluation performed.(b)(4).

Event Description

Customer reported via email: on (b)(6) 2016 in the evening resp.Therapy had a patient stating he was slightly sob.When pulse ox checked it was 77- he was on 6 l/m of 02 by nasal cannula airlife bubble humidifier / (b)(4).Once pt.Was stabilized on another 02 device.The bubble humidifier was accessed and found out to be producing little flow from the port and little bubbling.They tried on a couple other flow meters in other rooms and say no difference.They replace the faulty humidifier and pts.Saturation recovered.Reported item was being used on patient.No patient harm reported; medical intervention was required.Sample is available.Ups shipping label/ documents created and attached.No requested action at this time.

Manufacturer Narrative

(b)(4) (initial follow up).The complaint product was available and returned to carefusion.The product sample was sent to the manufacturing site for further evaluation.A series of tests were conducted on the sample product.The adapter insertion test consisted of manually threading the adapter to the bottle and the flow-meter.The adaptor was found to easily thread to both the bottle and the flow-meter.No abnormalities were found.The second test completed was for the backpressure, occlusion and adapter-bottle connection leakage.The test procedure performed consisted of removing the tabs from the humidifier bottle then assembling the adaptor to the bottle.The adaptor was then screwed onto the air hose with a 1/8¿ npt connector.The air flow valve was opened and set at 8l/min.The test was then to ensure the air pressure is at 50psi and verify that air is not leaking through the threads.The test also includes verifying that air is flowing through the bottle and escaping though the spigot(which should generate bubbles within the humidifier).Lastly once the flow is stabilized, the backpressure in the gauge must be confirmed.The acceptance criteria for this test is as follows: the bottle shall not have signs of air leakage, occlusion nor spitting.The backpressure shall be =0.92 psi.The test results did not show any sign of air leakage, occlusion nor spitting.The backpressure obtained was 0.39psi which is acceptable.The third test was for the humidification flux.The procedure consisted of measuring the difference of bottle weight after venting gas through the bottle without restrictions for two hours.The acceptance criteria is as follows: the humidification flux must be approximately 7.1 g/hr(std.Dev.= 0.6).The test results were at 6.9 g/hr.According to the expected value and deviation, variation was less than one standard deviation; therefore product performance is considered acceptable.According to the expected value and deviation, all testing passed and the returned product sample was found to be within specifications.The bottle and adaptor did not present any deviation from the validated design.(b)(4).

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Corrected data: investigation; completion date.

• Brand Name: HUMIDIFIER KIT 500ML
• Type of Device: RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5542634
• MDR Text Key: 41901137
• Report Number: 2031702-2016-00538
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 002620
• Device Catalogue Number: 002620
• Device Lot Number: TL1601142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Long-Term Care Facility
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/16/2016; 12/12/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention