MAUDE Adverse Event Report: CAREFUSION 2200, INC. STERILE WATER F/INHALATION INFLEX CONTAINERS

Catalog Number 2D0735X

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2014

Event Type  No Answer Provided  

Event Description

At 0830 the oscillator was set up using a manufacturer's water product.Three days later, there was no particulate noted in the canister.That same day (third day from set up), manufacturer's brand water was used in humidifier canister.On day 6 after set up, at 0900 an unknown substance was noted in the humidifier canister.This substance appeared to be white particulate matter.When the particulate was noted in the humidifier canister the products were discontinued from patient use and there was no patient harm.

• Brand Name: STERILE WATER F/INHALATION INFLEX CONTAINERS
• Type of Device: CONTAINER
• Manufacturer (Section D): CAREFUSION 2200, INC.; 17820 englewood dr.; cleveland OH 44130
• MDR Report Key: 4251131
• MDR Text Key: 5011606
• Report Number: 4251131
• Device Sequence Number: 0
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Device Operator: Invalid Data
• Device Catalogue Number: 2D0735X
• Device Lot Number: Q014262 2015 - 01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Patient Sequence Number: 1
• Treatment: G ITEMS: CAREFUSION WATER FOR INHALATION HUM; OSCILLATOR WAS IN USE ON PATIENT WITH THE FOLLOWIN; NO OTHER THERAPIES; IDIFIER CANNISTEROSCILLATOR CIRCUIT
• Patient Age: 6 DAY
• Patient Weight: 1