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

Model Number 22 E

Device Problems Misconnection (1399); Connection Problem (2900)

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".

• Brand Name: CAREFUSION
• Type of Device: CALCULATOR, 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 Key: 4992521
• MDR Text Key: 22584740
• Report Number: 2021710-2015-01383
• 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 faci
• Reporter Occupation: Health Professional
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22 E
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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