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

Model Number MICROBELNDER

Device Problems Defective Alarm (1014); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

The customer reported that the differential alarm is not working properly when the single gas is connected, it does not sound.Also the left side seems to have a leak from the flow meter.No patient involvement.

Manufacturer Narrative

(b)(4).The carefusion failure analysis technician evaluated the microblender and duplicated the customer complaint that the differential alarm is not working properly and that there is a leak at the left side alarm poppet cap.During the evaluation it was discovered that this microblender is more than 25 years old and should be replaced.

• 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: wendy schumacher ; 7607787219
• MDR Report Key: 4576494
• MDR Text Key: 20364971
• Report Number: 2021710-2015-00391
• 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: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBELNDER
• Device Catalogue Number: 15420
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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