MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Catalog Number 000000000000010110

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 08/12/2013

Event Type  No Answer Provided  

Event Description

The customer reported that after 60 minutes into the procedure, the operator observed foam and aggregates in the reservoir and air in the cassette circuit.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Additional evaluation for method: manufacturing review investigation: the disposable set was received for investigation.Upon visual inspection no foam was observed in the reservoir which was noted to be half full.No occlusion of the set was found.No kinks of the channel lines were noted.The run data file was analyzed for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this collection had an unresolved occlusion in the disposable, blocking the flow.This can be caused by a misload, clumping, or an air block impeding flow.A review of the images showed only slight signs of clumping.The door was never opened to check for loading, which can help resolve an air block.The system operated as intended by correctly noting the volume issue and alarming to direct the operator to remove any obstructions from the collect line, check for clots, and ensure the channel and lines are correctly loaded.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3787722
• MDR Text Key: 4381102
• Report Number: 1722028-2014-00156
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK120076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 04V3211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1