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

Model Number 22 E

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification: (b)(4).Patient demographics such as age, date of birth, gender, and weight were not provided by the customer.The carefusion field service engineer (fse) went on site to adjust co2 analyzer but the system still would not calibrate.The fse came back and installed a new vmax encore 22 system at the customer¿s facility and performed system verification.The new unit conformed to the manufacturer¿s published performance specifications and was returned to normal operation.Carefusion continues to track and trend any incident related to this issue.(b)(4).

Event Description

The customer reported having high frc during patient testing on the vmax encore 22 system; the customer has not performed a gas calibration before.The incorrect results were released to the physician; however the physician noticed the incorrect results.There was no report of patient impact associated with this event.The carefusion technical support (ts) explained to the customer on how to perform gas calibration and noted it failed twice after completing.The ts completed a diagnostic test on the unit and noted that the co2 baseline was high and did not increase to 1.6 volts.A carefusion field service engineer was scheduled to inspect the unit at the customer's facility and the customer will ordered a new replacement module.

Manufacturer Narrative

Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed no anomalies and physical damage.Testing of the unit continued by powering up the unit, and allowed to warm-up for 30 minutes.After 30 minutes, n2 calibration was performed, however the unit continued to fail.The c02 analyzer measured slope is < 0.5 or greater than 1.5.The slope on the lamp was too high.Investigation concludes that the co2 analyzer was determined to be faulty.The faulty c02 analyzer was replaced which resolved the reported issue.In conclusion, the likely cause of the event is attributed to the co2 analyzer.However, a definitive root cause is unknown.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: 5219018
• MDR Text Key: 31132257
• Report Number: 2021710-2015-02177
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/20/2015

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: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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