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

Model Number 22 E

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Any additional information received from the customer will be provided in a follow-up report.(b)(4).Carefusion has not received the suspect device from the customer.Carefusion file identification: (b)(4).

Event Description

The customer reported incomplete washout reaching and remaining at approximately 2% with and without balloons while performing pulmonary function analysis on a patient utilizing the vmax encore 22 instrument.Incorrect test results were generated and released to the physician.The customer then informed the physician of the incorrect results.The customer stated there was no patient impact associated with this event.Further system troubleshooting, with technical support, resulted in a replacement of the oxygen (o2) sensor but washout remained below 4%.The customer received a replacement unit and resumed pulmonary function analysis.No further issues were noted by the customer.

Manufacturer Narrative

Additional manufacturing narrative: factory analysis of the returned module was performed.The module was connected to a vmax test station (vm-3) and allowed the unit to warm up for 30 minutes.The laboratory then performed acceptance test procedure (atp): lung volume test yielded at 4.11b and functional residual capacity (frc) did not wash out; percentage (%) did not go below 4% and frc data spiked on the graph.The laboratory isolated the error to the oxygen (o2) sensor and carbon dioxide (co2) analyzer.In addition, it was noted the demand valve was slightly stiff.Power supply voltage was <15.00, remained at 14.71.The demand valve, power supply, o2 sensor, and co2 analyzer were replaced.Performance testing was performed, and the unit conformed to service specifications.In conclusion, the likely cause of the event is attributed to system software.However, a definitive root cause is unknown.Carefusion continues to track and trend any incident related to this issue.

Manufacturer Narrative

An evaluation of the co2 analyzer assembly device was performed.There was no visible external physical damage.The co2 analyzer was installed in the vmax encore 229 test unit and set to warm up (with the sample pump on) for 30 minutes.In the diagnostic test display, the ambient co2 reading was 0.017v and with the sample pump on it was 0.000v.With cal 1 gas on it went to 1.838v meeting the minimum required co2 specification of 1.6v.The exercise metabolic o2 and co2 analyzer calibration test was run several times and passed each time successfully.The lung volume n2 analyzer calibration test was run several times and passed each time successfully.The frc lung volume n2 wash test was performed three times and each time passed within specification (between 95% and 105% - meeting specification at 100% on average).The test was repeated and the results were similar.The complaint of the washout not falling below 4% was not duplicated.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: 5190203
• MDR Text Key: 30330662
• Report Number: 2021710-2015-02087
• 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: 09/24/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2016; 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2008
• 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