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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 Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2015
Event Type  Malfunction  
Manufacturer Narrative

The field service engineer (fse) assessed the unit and tested all subsystems and replaced the solenoid cable, double vent valve and the mass flow sensor (mfs) cable from the body box to the module. The fse was unable to get the calibrator motor to function and noted the voltage at j2 pin and at 24v, there was no power to the motor. The fse installed a new calibration shelf assembly and noted no power. The fse verified all electrical connections to the motor but was unable to receive power from pneumatics board. The fse replaced the pneumatics board and still was unable to power up the calibration shelf motor. The fse then discovered a missing ground connection and noted that the customer's biomedical engineer had misconnected the ground wire connection to pin 6 of the j2 power connector which damaged the mosfet connection. The fse ordered new pneumatics electronic enclosure. On 09/30/2015, the fse removed and replaced the pneumatics electronic enclosure. The fse then performed and completed body box atp and pb calibration, flow volume, and gas calibrations. The fse performed box leak constant test and adjusted values to within specification, inspire at 9. 8 and expire at 9. 9. The fse performed and completed pulmonary function test (pft) study and instructed the customer to perform a complete pft study. No issues were noted and all biologic standards were within specification. The instrument conformed to the manufacturer¿s published performance specifications and was returned to normal operation. Patient demographics such as age, date of birth, gender, and weight were not provided by the customer. (b)(4).

 
Event Description

The customer questioned the lung volume (lv) results while using the vmax encore system. The customer stated the device was utilized on a patient at the time of the event. The customer stated the patient's test results were released to the physician who later questioned the results, which were not used to make medical decisions. The patient had to be retested and corrected results were issued to the physician. The customer indicated other patients that did not begin the test had to be rescheduled. The customer stated it is unknown if patient treatment was delayed and that there has been no report of patient consequence associated with this event. Carefusion reviewed the results and noted that tidal breathing tracing increased to 7 liter mark following the test. Carefusion advised the customer to verify the unit prior to each study. The customer stated the unit was not near to any heating/cooling vents that would cause temperature drift. The customer performed troubleshooting with the biomedical engineer and could not hear the motor when attempted to calibrate the box pressure. The biomedical engineer replaced the sol cable and fuse but still the motor would not start for box pressure calibration. The customer later reported the volume calibrator motor would not start in diagnostics or during calibration. The customer requested service, and a carefusion field service engineer (fse) was dispatched to assess the instrument.

 
Manufacturer Narrative

Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed physical damages on the rear of the unit. Testing of the unit continued by connecting gas supply hoses to the rear of the unit, in which the gases were adjusted as follows: diffuse lung carbon monoxide (dlco) 80 psi, o2 = 60 psi, cal1 = 60 psi, cal2 = 60 psi, the unit was powered and allowed to warm-up for 30 minutes. Afterwards, diagnostics displayed, room air measures, pbar at 6. 195 vdc and co2 at 1. 798 vdc, o2 at 6. 274 vdc. A complete atp testing was performed without any issue and multiple calibrations were completed successfully. The covers was removed to check for internal damages; all connections to and from the unit were intact and fully inserted. In an effort to duplicate the customer reported issue, the vmax module was tested in conjunction with the body box and no issue was noted. In conclusion, a definitive root cause of the incident could not be determined. The returned vmax module was evaluated, and the reported failure could not be duplicated. Carefusion continues to track and trend any incident related to this issue.

 
Manufacturer Narrative

Results of investigation: the motor cable assembly was evaluated by the (b)(4) failure analysis lab and the reported issue could not be duplicated. No problems could be detected so no root cause could be determined. After further review this malfunction was determined to be unlikely to cause harm to a patient if the issue were to reoccur.

 
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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 Key5158009
MDR Text Key28753176
Report Number2021710-2015-01919
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 09/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2015
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 Manufacturer10/09/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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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