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

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).

• Brand Name: CAREFUSION
• Type of Device: CALCULATOR, 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 Key: 4457039
• MDR Text Key: 5320507
• Report Number: 2021710-2015-00128
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• 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 Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2014
• Distributor Facility Aware Date: 11/05/2014
• Device Age: 6 YR
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other