MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX® BIVONA® MID-RANGE AIRE-CUF® ADULT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 750180

Device Problems Product Quality Problem (1506); Material Deformation (2976)

Patient Problem Sudden Cardiac Death (2510)

Event Type  Death  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.Event date: end of the month of (b)(6) 2017.

Event Description

It was reported that the patient was using a bivona® 8.0mm aire-cuf tracheostomy tube and the pilot balloon was over inflating on one side and causing some trouble a with ventilation on a home bound trached patient.The fault was discovered while testing the cuff patency prior to use with air by the spouse/caregiver/nurse as well as respiratory therapist.Significant ventilation issues were noticed 7-10 days prior to death, the patient was ultimately unresponsive to tracheostomy changes and deep suctioning.It was also reported that these events happened on 3 tracheostomy tubes and the last "live" download was on (b)(6) 2017, indicating high pip (peak inspiratory pressure) alarm started to frequently develop about 10 days prior to death.The patient was switched back to a different manufacture tracheostomy tube on (b)(6) 2017, before the time of sudden death.It was reported that the assumed death was due to cardiac arrest not an airway issue.

Manufacturer Narrative

The customer returned thirteen devices for investigation.Eleven of the devices corresponded to a non-reportable complaint and two devices were associated with two reportable complaints.It could not be determined which device was associated with which occurrence; therefore, the investigation of the thirteen devices will be used for the medwatch.The following mfr were submitted related to the evaluation: 3012307300-2017, 00514 and 3012307300-2017-00628.Thirteen portex® bivona® mid-range aire-cuf® adult tracheostomy tubes of varying sizes were returned for investigation.The thirteen devices were randomly assigned a number for investigation.Visual inspection of the devices was performed using the unaided eye and under normal plant lighting.No obvious defects or anomalies were detected with twelve of the devices.One device, identified as number six, displayed wear marks on the cuff.During functional testing all thirteen devices were inflated with 10ml of air.The cuff symmetry was then measured for each device by measuring from the center point of the shaft to the smaller side of the outer diameter of the cuff and then by measuring from the center point of the shaft to the larger outer diameter of the cuff.All returned devices were determined to meet manufacturing specification allowance for aire-cuf® devices.Investigation was unable to confirm the reported issue and all devices were found to operate as intended.

• Brand Name: PORTEX® BIVONA® MID-RANGE AIRE-CUF® ADULT TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6354679
• MDR Text Key: 68184120
• Report Number: 3012307300-2017-00514
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2021
• Device Catalogue Number: 750180
• Device Lot Number: 3272409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 84