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

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.

• 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: 5158009
• MDR Text Key: 28753176
• Report Number: 2021710-2015-01919
• 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: Followup,Followup
• Report Date: 09/18/2015

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: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/10/2015; 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2006
• 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