MAUDE Adverse Event Report: CAREFUSION, INC P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

Carefusion file identification: (b)(6).Any additional information received from the customer will be included in a follow-up report.(b)(4).The suspect device will be sent to carefusion (b)(4) for evaluation/repair.Once a final investigation is completed, a supplemental report will be submitted.

Event Description

The customer reported while using the low flow air/oxygen microblender; the customer reported being unable to regulate the oxygen levels.The customer reported there is no patient involvement associated with the event.

Manufacturer Narrative

The suspect blender was returned for vyaire's factory service in germany.The reported event was able to be verified and duplicated.The blender knob and flowmeter are damaged.After replacing the blender knob and flowmeter, the issue was resolved.Overhaul and calibration were performed and the device meets service specifications.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6652320
• MDR Text Key: 78027007
• Report Number: 2021710-2017-06144
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 10017A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1