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U.S. Department of Health and Human Services

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

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CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problem Incorrect, Inadequate or Imprecise Resultor 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.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, 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 Key5190203
MDR Text Key30330662
Report Number2021710-2015-02087
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
PMA/PMN NumberK981366
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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