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U.S. Department of Health and Human Services

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

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CAREFUSION CAREFUSION CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problems Regulator (932); Misconnection (1399); Connection Problem (2900); Hose (3072)
Patient Problem Irritation (1941)
Event Date 05/22/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). The non-carefusion provided dlco gas regulator was not returned to assess the fittings. Only the dlco hose (part number 770215) was received for evaluation. The hose was visually inspected with no abnormalities observed. The hose was connected to a standard test set-up and pressurized. There were no bulges ("bubbling") or leaks detected during the testing.

 
Event Description

The registered respiratory therapist called to request a replacement dlco hose for her system with the allegation that the hose has a "bubble". A replacement hose was sent; however the clinician returned the call after receipt indicating that she required an adaptor to enable her to connect the hose to the dlco gas regulator. The regulator in use at the facility was not a carefusion provided regulator. Upon further follow-up with the clinician she advised us that for more than two weeks she was "dizzy, with headaches and coughing, before detecting the leak, i had to open the windows constantly because i was always coughing and irritated, all of which were alleviated when the leak was contained by the replacement of the hose and proper seal".

 
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Brand NameCAREFUSION
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
2627587805
MDR Report Key4992521
MDR Text Key22584740
Report Number2021710-2015-01383
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777404-101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/10/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/07/2009
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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