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

Catalog Number 000000000000010110

Device Problems Pressure Problem (3012); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Code Available (3191)

Event Date 09/20/2013

Event Type  No Answer Provided  

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure, the operator noted aggregates in the chamber and experienced pressure problems.The procedure was ended prematurely.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 loca lauthorities.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.No defects were noted in the set.No aggregates were noted in the cassette.The access and return luers were flow tested and inspected; no issues were noted.The run data file (rdf) was analyzed for this event.There were multiple 'inlet pressure too low' pauses, and the last three chambers were collected manually because they were taking too longto be triggered by the rbc detector.A review of the lot for similar reports was carried out, none have been reported.Root cause: the rdf images show signs of some slight clumping.There were also signs of buffy coat accumulation in the reservoir which could be why the chambers were taking a long time to trigger.A platelet clump may be observed being pumped through the collect port.It is best to eliminate the clump and stop the clotting cascade as quickly as possible by adjusting the ac inlet ratio.Buffy coat accumulation can be seen through the view port, a steady defined buffy coat should not accumulate in the connector above the skimmer dam.This is most likely to occur with patients with high counts and if the pumps have paused several times.Adjusting collection preference can eliminate the buffy coat.

• 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: 3667106
• MDR Text Key: 4320733
• Report Number: 1722028-2014-00071
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK120012
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 07V3117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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