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

Model Number MICROBLENDER

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  Injury  

Event Description

The following description of the event was copied from a carefusion ventilation complaint form submitted on behalf of user facility in (b)(6) by the distributor in (b)(6)."hospital med tech department has checked blender gas alarm function, after they have heard from user at their hospital that during a pt transport in (b)(6), gas alarm didn't work properly.Someone forgot to turn on the oxygen bottle, only air.According to [name removed], they didn't know pn/sn.They have not received any report of any pt harm.".

Manufacturer Narrative

Carefusion does not have any info at present in regards to the effect of the lack of supplemental oxygen on the pt during the reported event.As the lack of supplemental oxygen could cause a serious injury, carefusion has decided to report this event as a serious injury.Neither the foreign user facility nor the foreign distributor submitted a user facility/importer report to the manufacturer.Event codes were derived based on info provided by the foreign distributor.(b)(4).The foreign user facility determined that the cause of the pt only receiving air during transport was that one of their staff did not turn on the oxygen cylinder to provide oxygen to the device additionally, as a contributing factor to the event it appears as though the staff did not heed the following warnings in the micro-blender instruction manual: the pt gas must be monitored with an oxygen analyzer.Adjustment of the oxygen concentration must be verified using an oxygen analyzer.The foreign user facility also determined that the most likely cause of the reported gas alarm not working was a malfunctioning alarm cap assembly.Carefusion is attempting of gather additional info regarding the reported event, disposition of the pt and info on any evaluation of the device performed by the foreign user facility.Based on the info that carefusion has at present it does not appear that the foreign user facility documented this event in any type of official report.Therefore they have no record of the device's part number, serial number nor which pt the event occurred on.Should carefusion obtain additional info, a follow-up medwatch report will be submitted.

• Brand Name: BIRD
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION/BZR
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: james stytle ; 7608837120
• MDR Report Key: 4462326
• MDR Text Key: 5189219
• Report Number: 2021710-2015-00111
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Outcome(s): Required Intervention