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

Model Number MICROBLENDER

Device Problem Inaccurate Delivery (2339)

Patient Problems Respiratory Distress (2045); Abdominal Distention (2601)

Event Date 05/25/2014

Event Type  Injury  

Event Description

The following information concerning the reported event was copied from a carefusion ventilation complaint form that was submitted to carefusion by the distributor in (b)(4).On (b)(4) 2014 [distributor's name removed] was contacted by [name removed] from the neonatal clinic at [facility name removed].The subject of the conversation was concerning a serious incident in regard to an oxymixer, which gave only atmospheric air inspite the o2 setting was at 100%.Ther serious incident was reported to the [competent authority name removed] by [facility name removed] on (b)(6) 2014.[distributor's name removed] acts as a distributor to the device, where this device is part of a kit delivered by [distributor's name removed], and as such we have chosen to investigate this case.We believe our investigation could be of help to the [competent authority name removed].The kit was invoiced from [distributor's name removed] to [facility name removed] on (b)(6) 2008.Device labeling states that the manufacturer is [manufacturer's name and address removed].Notified body: (b)(4).In (b)(6), the responsibility for this device lies with [company name and address removed].In regards to this case we have been in contact with [name removed], business manager.In order to investigate the incident further, we have had follow up contact with [name removed] and [name removed] from [facility name removed].

Manufacturer Narrative

We have received the following information: the root cause for the incident is the turning knob on the front of the device ([manufacturer's name removed] low flow air/o2 blender), which regulates o2 concentration.The turning button was loose and did not interact with the shaft of the oxygen regulator mechanism.Personnel would by turning the knob assume, that a given oxygen amount would be delivered, but none was.The last calibration of the device was performed in (b)(4) 2013 by a technician from [facility name removed].[distributor's name removed] has registered this event in our complaint handling system.With this correspondence, we assume the case to be closed.However should further questions arise, please feel free to contact us.Result of the incident: danger and genes.Delayed transfer to home hospital.Increased side effects (abdominal distension as a result of high cpap pressure).Reduced nutrition and fluid intake.Unnecessary antibiotic therapy.The child got a higher cpap pressure than necessary, higher than otherwise indicated, and it was pure luke that he did not become intubated due to respiratory deterioration (he was perceived as inadequate despite 100% oxygen in nacalcpap).Neither the foreign user facility nor the foreign distributor submitted a user/facility importer report to the manufacturer.Event codes were derived based on information provided by the foreign distributor.(b)(4).The alleged faulty device was received by carefusion on (b)(4) 2014 routed to the carefusion failure analysis lab and staged for evaluation.Once the evaluation is complete a follow-up medwatch report will be submitted.Carefusion anticipates that the follow-up medwatch report will be submitted on or before (b)(4) 2014.

Manufacturer Narrative

The following information concerning the evaluation of the device is a summary of the information documented by the carefusion failure analysis lab technician and the carefusion factory service representative.The carefusion failure analysis lab technician evaluated the 03800a microblender and was able to verify the complaint of the 03800a microblender delivering 21% oxygen when set to deliver 100% oxygen.The failure analysis lab technician found that the 03800a microblender's control knob was loose on the front valve stem, thus turning the control knob did not turn the front valve stem and adjust the o2 concentration level.Therefore, the 03800a microblender was not delivering the prescribed 02 concentration.The failure analysis lab technician was not able to determine how the collet nut that secures the control knob to the front valve stem became loose as per the service manual it should be torqued to 4 inch/pounds.Additionally, as a contributing factor to the event it appears as though the staff did not heed the following warnings in the microblender instruction manual; the patient gas must be monitored with an oxygen analyzer.Adjustment of the oxygen concentration must be verified using an oxygen analyzer.Following the evaluation in the carefusion failure analysis lab, the 03800a microblender was routed to the carefusion factory service department.Carefusion factory service department could not find any factory service history on the 03800a microblender and therefore recommended that the 03800a microblender be overhauled.The 03800a microblender is 6 years old and carefusion recommends an overhaul every 2 years.The carefusion factory service representative performed an overhaul on the 03800a microblender which included a complete calibration and testing per the service department procedures.Upon completion, the 03800a microblender was returned to the user facility ready to be placed back into service.A review of the carefusion complaint system for the past 180 days resulted in zero like failures (same alleged symptom & failure mode) of the 03800a microblender; therefore carefusion considers this to be an isolated incident.

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.Correction: user facility/importer information was reported in error on initial mdr.Information redacted.

• Brand Name: BIRD
• 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 ; 1100 bird center dr.; palm springs, CA 92262 ; 7149227830
• MDR Report Key: 3955175
• MDR Text Key: 4559127
• Report Number: 2021710-2014-00041
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• 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: 03800A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/25/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2008
• 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
• Treatment: ASKU; BENVENISTE CPAPGENERATING VALVE; FISCHER PAYKEL HUMIDIFIER; PHILIPS MONITOR; ASKU
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 1 KG