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

Model Number 22 E

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) assessed the unit and noted the analyzer responded incorrectly to gas calibration and verified gas tank pressures.The fse discovered a faulty oxygen (o2) cell sensor and replaced the senor to resolve the reported issue.The fse then allowed the unit to warm up and re-verified all o2 responses returned to normal ranges.The fse performed a functional residual capacity (frc) calibration and it passed within specifications.An frc validation procedure was also performed and completed at 98% of target.The customer indicated the questioned device will not be returned to carefusion.The unit was returned to normal operation.No further issues were noted by the customer.(b)(4).In conclusion, the likely cause of the event is attributed to the o2 cell sensor.However, a definitive root cause is unknown with the available information.Carefusion continues to track and trend any incident related to this issue.

Event Description

The customer reported gas calibration issue while using the vmax encore 22 pulmonary function analysis instrument.A patient was being tested at the time of the reported issue, and test results were generated and released to the physician.The customer then noticed the results were erroneous and informed the physician; the results were not used in making a diagnosis.The customer stated there was no patient impact associated with this event.A field service engineer (fse) was dispatched to assess instrument.

Manufacturer Narrative

Additional information from field service: the field service engineer (fse) verified the issue with o2 cell - reading at 0.100 with the pump on.The fse removed the faulty o2 cell and installed a new o2 cell.The fse allowed the unit to warm up then performed verifications - all o2 responses returned to normal.The fse performed functional residual capacity (frc) analyzer calibration and it passed multiple times.The fse performed frc validation procedure and it was 98% of target.

Manufacturer Narrative

Device evaluation: an evaluation of the returned device was performed.Visual inspection of the received o2 analyzer assembly noted no issues.The service technician connected the o2 analyzer to a known good vmax test unit and noted the o2 reading did not change after o2 was supplied.The technician confirmed it failed the analyzer calibration per lung volumes test, per the manufacturing procedure.The reported issue was able to be duplicated.In conclusion, the likely cause of the event is attributed to the o2 analyzer assembly.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: 5248525
• MDR Text Key: 32204310
• Report Number: 2021710-2015-02323
• 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,Followup
• Report Date: 11/02/2015

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: 777543-102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2016; 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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