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U.S. Department of Health and Human Services

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

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CAREFUSION CAREFUSION CALUCALATOR, PREDICTED VALUES, PULMONARY FUNCTION/BT Back to Search Results
Model Number VMAX ENCORE 22
Device Problem Failure to Calibrate
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.

 
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Brand NameCAREFUSION
Type of DeviceCALUCALATOR, 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 Key4765741
Report Number2021710-2015-00953
Device Sequence Number1
Product CodeBTY
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22
Device Catalogue Number777404-101
OTHER Device ID NumberCMP154817
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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