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

Model Number MICROBLENDER

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

The following description of the event was copied from an email submitted by the foreign distributor."the blender is not alarming when the one gas is not plugged.I replaced the alarm bypass and it worked.".

Manufacturer Narrative

The foreign distributor did not submit a user facility/importer report to the mfr.Event codes were derived based on info provided by the foreign distributor.The following info concerning the eval of the device is a summary of the info documented by the foreign distributor.The foreign distributor's rep determined that the root cause of the reported event was a failed blender bypass alarm assembly.The foreign distributor repaired the device by replacing the blender bypass alarm assembly with one from their stock.Carefusion has requested from the foreign distributor the return of the alleged faulty blender bypass alarm assembly for eval.As of (b)(4) 2014 the alleged faulty blender bypass alarm assembly has not been received by carefusion.However, this type of failure allegation is generally caused by the application of an unapproved means of force or pressure against the reed on the alarm reed plate which is part of the blender bypass alarm assembly.Should the alleged faulty blender bypass alarm assembly be received for eval, carefusion will submit a f/u medwatch report.

Manufacturer Narrative

This supplemental report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The original date of awareness is (b)(6) 2014; this information was noted on 9/21/2015.Examination of the returned alarm cap p/n: 05436 found that the reed of the reed plate p/n: 01866 was stuck down into its slot.It was verified that the alarm would not sound.Had (b)(6) 2015 for the date of the event and report.This was an error.The actual date should be (b)(6) 2104.The failed component of the device was returned to the manufacture for analysis.Information redacted from initial mdr, submitted in error.The evaluation codes were updated to reflect the evaluation of the returned component.

• Brand Name: MIRCOBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 3958099
• MDR Text Key: 4606864
• Report Number: 2021710-2014-00029
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

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: Other
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03800A
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/15/2014
• Device Age: 2 YR
• Event Location: Other
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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