MAUDE Adverse Event Report: CAREFUSION, INC AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number AVEA

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Hypoventilation (1916); Respiratory Acidosis (2482)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device trained customer has reported testing and servicing the device; no return good authorization (rga) has been issued.An onsite end user training by carefusion has been provided as the customer has identified that no failure has been detected.It is believed to be a clinical training issue in which the contextual use of the device contributed to the perceived issues.At this time, carefusion has not received the suspect device for evaluation.

Event Description

The customer reported an unresolved circuit occlusion alarm on this avea ventilator while in patient use.The customer reported the patient experienced a high reading in the arterial partial pressure of carbon dioxide (paco2) the patient was removed and placed on an alternate ventilator.The customer reported that the device was in airway pressure relief ventilation (aprv) mode with inhaled "flolan" being nebulized into the patient circuit during the time of the reported issues.The customer used the same patient circuit and placed the patient with this avea ventilator.After several hours of use, the same issue repeated itself, so the ventilator was switched out with a new ventilator and new circuit.The patient was ventilated with the new device and set up without further issues.The device trained customer received the device and reported the event was not duplicated in the biomed department.

• Brand Name: AVEA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 6422340
• MDR Text Key: 70520410
• Report Number: 2021710-2017-05641
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVEA
• Device Catalogue Number: 17212-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2004
• 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
• Patient Outcome(s): Required Intervention