MAUDE Adverse Event Report: CAREFUSION CAREFUSION; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problems No Audible Alarm (1019); Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2014

Event Type  malfunction  

Manufacturer Narrative

The user facility did not submit a user facility report to the mfr.The following info concerning the eval of the device is a summary of the info documented by the carefusion factory service rep.The carefusion factory service rep evaluated the device, verified the complaint and determined the issue was caused by the device being out of calibration.Unfortunately the carefusion factory service rep was not able to determine how or what caused the device to go out of calibration.Once the device was calibrated in accordance with carefusion factory service procedures it operated to factory specs.Upon completion, the device was returned to the user facility ready to be placed back into service.

Event Description

The following description of the event was documented by a carefusion tech support specialist in response to a phone conversation with a user facility rep(s)."the customer is sending the unit in for repair the customer indicates unit does not deliver fio2 per spec.Issue noted during check off pt use." the following description of the event was documented by a carefusion field service rep in response to an onsite visit." "the blender was not alarming with one gas source.".

• Brand Name: CAREFUSION
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: antonio cervera
• MDR Report Key: 4286537
• MDR Text Key: 59523137
• Report Number: 2021710-2014-00072
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: Yes
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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