MAUDE Adverse Event Report: SMITHS MEDICAL INT'L LTD THERMOVENT T - HEAT AND MOISTURE EXCHANGER (HME)

Catalog Number 100/570/015

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2014

Event Type  Injury  

Event Description

A report was received stating the filter from the heat and moisture exchanger fragmented after 3-4 hours in use with a pt.It was reported that a piece of the fragmented filter was discovered during suctioning the pt.A bronchoscopy was performed, add'l fragments were observed and removed from the pt.No permanent adverse effects to the pt reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full eval is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a f/u report detailing the results of the eval once it is completed.

• Brand Name: THERMOVENT T - HEAT AND MOISTURE EXCHANGER (HME)
• Manufacturer (Section D): SMITHS MEDICAL INT'L LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INT'L LTD; boundry rd; hythe, kent CT21 6JL; UK CT216JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4129070
• MDR Text Key: 4935045
• Report Number: 2183502-2014-00697
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Catalogue Number: 100/570/015
• Device Lot Number: 2546486
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2014
• Distributor Facility Aware Date: 08/25/2014
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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): Required Intervention