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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 High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2015
Event Type  Malfunction  
Manufacturer Narrative

Patient demographics such as age, date of birth, gender, and weight were not provided by the customer. A definitive root cause of the event could not be determined with the available information. Carefusion continues to track and trend any incident related to this issue. (b)(4). All related medwatch reports associated with this incident: 2021710-2015-01924, 2021710-2015-01925, 2021710-2015-01926, 2021710-2015-01934, 2021710-2015-01935, 2021710-2015-01936, 2021710-2015-01937, 2021710-2015-01938, 2021710-2015-01939, 2021710-2015-01940, 2021710-2015-01942, 2021710-2015-01943, 2021710-2015-01944, 2021710-2015-01945, 2021710-2015-01946, 2021710-2015-01947, 2021710-2015-01948, 2021710-2015-01949, 2021710-2015-01950, 2021710-2015-01951, 2021710-2015-01962, 2021710-2015-01964,, 2021710-2015-01965, 2021710-2015-01966, 2021710-2015-01968, 2021710-2015-01970, 2021710-2015-01972, 2021710-2015-01973. (b)(4).

 
Event Description

The customer reported questionable elevated diffuse lung carbon monoxide (dlco) values for twenty-eight (28) patients for pulmonary function analysis while utilizing the vmax encore 22 system. This report is for patient one of twenty-eight. The customer stated all 28 patients' results were released to the physician; however, there was no patient impact. The customer informed the physician of the incorrect results prior to any medical decision. The customer stated the 28 patients were retested and corrected results were issued to the physician. The customer also noted there was no system alarm at the time of the reported issue. The data received from the customer did not show issues with gas tracings, and no errors were noted. Notable were larger than normal inspiratory vital capacity (ivc), and alveolar volume (va) values, which were likely responsible for dlco values in excess of 160% reference for multiple patients that were being tested. The customer replaced all lines and tubing, as well as the mass flow sensor (mfs) and balloon valve assembly (bva) prior to the event. Review of the most recent mfs calibration, (which passed without error) shows correction factors as: inspire = 1. 68 lps expire = 1. 92 lps. The customer was then instructed to examine the calibration hose and noticed a large tear in the hose. The customer replaced the calibration hose and noted the correction factors were approximately 1. 007 lps for inspire and expire. The reported issue was resolved, and the unit was returned to normal operation. No further issues were noted.

 
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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 Key5169160
MDR Text Key29301670
Report Number2021710-2015-01924
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
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
Report Date 09/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777543-102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/01/2010
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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