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

Model Number 22 E

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

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 low functional residual capacity (frc) while performing pulmonary function analysis on a patient using the vmax encore 22 instrument.Incorrect test results were generated and released to the physician; however, there was no patient impact associated with the event.The customer indicated the unit did not washout at an expected length of time and displayed spikes.Further system troubleshooting was performed, however a clear cause could not be confirmed.The customer received a new unit, and it is currently in full operation.No further issues were noted by the customer.

Manufacturer Narrative

An evaluation of the returned vmax encore unit was performed.Visual examination of the vmax module revealed no anomalies and/or physical damage.The vmax module was powered up and allowed to warm up for 30 minutes.After the warm-up, diagnostic display all functioned normally.The technician performed multiple gas calibrations and all calibrations passed without any issue.The technician noticed that during functional residual capacity (frc) test, the demand valve free flowed excessively, causing a leak during the test.The technician replaced the demand valve and retested frc which passed within specification.The technician also replaced the co2 analyzer and power supply as precautionary measures.It was noted that the co2 analyzer and power supply had no serial or lot number for traceability.The technician could not duplicate the ¿o2 blowing out of the back of the module¿ issue, noting possible external factors.The reported issue was duplicated.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: 5184440
• MDR Text Key: 30066733
• Report Number: 2021710-2015-02059
• 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: 10/13/2015

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: 777543-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• 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