MAUDE Adverse Event Report: CAREFUSION STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 22D E

Device Problem Calibration Problem (2890)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) assessed the unit onsite and heard pressure buildup in the diffuse lung carbon monoxide (dlco) regulator.The fse replaced the regulator and noticed no gas was released during inspire and noted the demand valve was flushing through the breathing valve but not opening at inspire - no gas available other than a flush; negative pressure was applied to the tubing in the box and at the rear of the box but the demand valve still did not open.The customer will return the suspect device to carefusion.(b)(4).Carefusion has not received the suspect device from the customer.(b)(4).

Event Description

The customer could not inspire diffuse lung carbon monoxide (dlco) gas while utilizing the vmax encore 22 pulmonary function analysis instrument.The customer stated one dlco maneuver had been completed, and the instrument was calibrating for the second trial when the event occurred.The device was in use on a patient at the time of the event, and test results were released to the physician with a note explaining why only one maneuver was performed.The customer stated there was no patient injury with this event and noted the pressure buildup made a tremendous noise.The customer used an alternate vmax encore system from a sister hospital and continued testing the following day.As a resolution, the customer ordered a new vmax encore unit for use.A carefusion field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The customer stated the dlco hose inner lining ruptured and a bulge in the tubing.Analysis of the returned diffuse lung carbon monoxide (dlco) hose assembly revealed one area of the dlco hose had delamination of approximately 70 mm long.Functional testing was performed by connecting the dlco hose from the dlco regulator to the vmax module; the dlco hose was pressurized to 80 psi.The hose was inspected under water for any bulges or significant expansion and/or water bubbles to determine if the inner hose may be ruptured.Area of the hose, where the delamination occurred, did not pressurize with dlco gas indicating that an internal hose rupture did not take place.The delamination section of the hose was then peeled to determine for any leaks and/or rupture in the dlco hose; none were noted (the dlco hose did expand slightly, which is to be expected).The dlco hose was then pressurized for one (1) hour.After one (1) hour, the area of the hose, where delamination occurred, did not pressurize with dlco gas.The customer reported issue (bulging of hose) could not be confirmed, however, a significant delamination did occur.The precise age of the hose could not be determined due to lack of serialization and/or lot number on the returned hose.In conclusion, a definitive root cause is unknown with the available information.Carefusion continues to track and trend any incident related to this issue.

Manufacturer Narrative

Correction: result/conclusion.Further evaluation of the returned unit revealed an aged o2 sensor, sample pump, and a broken stand off for power supply on the chassis and replaced with a new chassis.The evaluation concluded a faulty demand valve; a replacement demand valve was installed on the unit.Performance testing was completed, and the unit conformed to all service specifications.In conclusion, the likely cause of the event is attributed to the demand valve.However, a definitive root cause is unknown with the available information.Carefusion continues to track and trend any incident related to this issue.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5175614
• MDR Text Key: 29848029
• Report Number: 2021710-2015-02042
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2015

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: Health Professional
• Device Model Number: 22D E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2015; 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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