N
Patient 1
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).
MAUDE MDR 5190203
- MDR report key
- 5190203
- Report number
- 2021710-2015-02087
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-09-24
- Date received
- 2015-10-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JILL RITTORNO
- Address
- 75 N. FAIRWAY DRIVE VERNON HILLS IL 60061 US
- Phone
- 847-847-8473
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STATIC AND DYNAMIC COMPLIANCE | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION | CAREFUSION | BTY | 22 E | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-30 | 0 |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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
N
Patient 1
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.