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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 09/24/2015
Event Type  Injury  
Manufacturer Narrative

The patient's date of birth and weight were not provided by the customer. Any additional information received from the customer will be provided in a follow-up report. (b)(4). The suspect device has been received and is currently in evaluation. (b)(4).

 
Event Description

The customer reported oxygen (o2)/carbon dioxide (co2) and diffuse lung carbon monoxide (dlco) calibrations failed while in use involving the vmax encore 22 pulmonary function analysis instrument. The customer stated the device was utilized on a patient for pulmonary function testing (pft) at the time of the event, and the patient's test results were released to the physician. The physician then noted the results were lower than predicted and believed chemotherapy was the cause of the patient's low pft results. Consequently, the physician stopped the patient's chemotherapy treatment. The customer has not informed the physician of the patient's false results and stated that the physician will not be informed. The customer stated that there has been no report of patient consequence and that the patient is currently under surveillance. The customer also noted diffusion was low at the time of the event. The customer stated no further patient status/information will be retrieved from the physician. The customer ordered a new vmax encore 22 instrument and placed it in operation. No additional information has been provided by the customer at present. The suspect device has been returned to carefusion for analysis.

 
Manufacturer Narrative

Failure analysis of the returned material: visual examination of the vmax module as received revealed no anomalies and or physical damage. Electrical check/room air measures displayed a normal pbar of 7. 501 vdc; pbar room air at 6. 195 vdc; o2 sensot at 6. 112 vdc; and co2 at 1. 795 vdc. Verification testing followed by connecting the 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; co2 at 1. 795 vdc; and o2 at 6. 112 vdc. Several calibrations were performed. The first calibration failed; however, the second calibration passed (no adjustments were made to the vmax module). After 20 minutes, multiple calibrations were performed which were very unstable; calibration passed and at times, failed. In addition, the cover was removed to check for internal damages; all connections to and from the unit were intact and fully inserted. The customer¿s reported issue was able to be duplicated. In conclusion, the likely cause of the event is attributed to the co2 analyzer. A definitive root cause is unknown. 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 Key5171794
MDR Text Key29175448
Report Number2021710-2015-01995
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
1 Patient Was Involved in the Event
Date FDA Received10/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777404-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/24/2015 Patient Sequence Number: 1
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