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

Model Number VMAX ENCORE 22

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The following description of the event was documented by a carefusion technical support specialist in response to a phone conversation with a user of our device: "flowsensor calibration problem.Getting warning that marginal correction factor is out of range (1.95-2.00) he just installed this flowsensor lot number be0311.Asked him to inspect the cal syringe hose for ters or holes.He says there are tears in the hose.Asked him to change it out, he will use another 32 liter syringe and hose from another system and try calibration again." customer was concerned that once he recognized that the correction factors were out of range that he would require retesting of previously tested patients.

Manufacturer Narrative

The tubing with the hole was discarded by the user facility and therefore could not be returned to carefusion for further examination to draw any conclusions.A follow-up call was made by customer advocate to determine if after replacing the syringe hose and mass flow sensor and recalibrating the unit if the issue was resolved and the customer indicated that it has been resolved.The tubing with the hole was discarded by the user facility and therefore could not be returned to carefusion for further examination to draw any further conclusions.

• Brand Name: CAREFUSION
• Type of Device: CALUCALATOR, 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: jill rittorno ; 8473628056
• MDR Report Key: 4765741
• MDR Text Key: 20124044
• Report Number: 2021710-2015-00953
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Other Device ID Number: CMP154817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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