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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION/BT

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CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION/BT Back to Search Results
Model Number VMAX ENCORE 22
Device Problem Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2014
Event Type  Malfunction  
Event Description

The following descriptions of the event were documented by a carefusion technical support specialist in response to a phone conversation with a user facility representative. "problems with volumes, both in dlco and fvl. Changed out mfs seemed to come in okay after mfs cleaning on cal screen. She will monitor testing today and call back if needed and definitely call back in the morning once morning work up completed. " :spoke with customer again, volumes shifting at times seems to be totally inconsistent in volume measurement intermittent will dispatch for on site, customer will have po. " the following description of the event was copied from the user facility medwatch report received by carefusion from the fda on 12/23/2014. "title: xxxxx. Event description: there was a drift in average correction factors on the pulmonary function testing (pft) machine; result in the possibilities of unreliable results. It was discovered that there was a leak in a tube. " "manufacturer response for the pft machine and bodybox, carefusion vmax pft machine (per site reporter). " "carefusion tech serviceman came and discovered the leak in a tube and corrected the problem and serviced it. Also evaluated the pft machine for any further issues - there was none. Service tech suggested ways to recheck for leaks. " "what was the original intended procedure: pft testing. " "device usage problem: device malfunction - that is, the device did not do what it was supposed to do. ".

 
Manufacturer Narrative

The user facility did not provide any patient or device codes on their user facility report. Codes were derived based on the information provided by the user facility of the user facility medwatch report received from the fda on 12/23/2014 and information documented by a carefusion technical support specialist on 11/25/2014 and 11/26/2014 in response to phone conversations with a user facility representative. The carefusion field service representative visited the user facility and evaluated the pulmonary function testing system and verified the reported issue. The carefusion field service representative found that there was a crack in the calibration hose (tube) where it connects to the calibration syringe causing a leak during calibration of the system. The carefusion field system representative replaced the calibration hose (tube), recalibrated the system and verified that the system was functioning as intended. The carefusion field service representative advised the user facility to watch for consistency when performing calibration of the system. (b)(4).

 
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Brand NameCAREFUSION
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION/BT
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
james stytle
7608837120
MDR Report Key4457039
MDR Text Key5320507
Report Number2021710-2015-00128
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 Other,Health Professional,User facility
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 12/01/2014,11/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberVMAX ENCORE 22
Device Catalogue Number777404-101
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2014
Distributor Facility Aware Date11/05/2014
Device Age6 yr
Event Location Other
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/23/2015 Patient Sequence Number: 1
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