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

Catalog Number 000000000000010110

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

The customer reported that they observed clumping in the collection bag after a mononuclear cell collection (mnc) procedure.Per the customer, during the harvest, the blood was clear and there were no obvious clots.The customer sent the collected product to the lab for testing and confirmed that the collected product contained fibrin-type clots.The collected product was discarded by the customer.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable kit is not available for return because it was discarded by the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: per the customer, iv calcium was administered prophylactically during the procedure, there were no symptoms of citrate toxicity.The customer stated that the procedure was run the following day on a different machine.They experienced access pressure alarms and clotting in the inlet pressure sensor, and the procedure was discontinued.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed non circularities during manufacturing that were relevant to this issue the run data files (rdfs) were analyzed for this event.Root cause: signals in the rdfs show there were minor signs of clumping in the collect port for both procedures.The images were reviewed for both procedures and there were a few images that were indicative of platelet clumping in the collect port.The inlet:ac ratio was at 12:1 throughout the procedure without any adjustments.If there are any signs of clumping during the procedure, it is suggested to decrease the ac ratio temporarily until the clump is cleared, and to assess the reservoir filter for excessive clumping that could cause an obstruction i the reservoir.It is also possible that the clumping may be patient related.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependant on a specific platelet count and varies by patient.Therefore, every procedure should be observed for platelet clumping in the connector or the collect port.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.This supplement is being filed to modify information to align with the reported event.

• 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: 4038328
• MDR Text Key: 4865486
• Report Number: 1722028-2014-00339
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K131744
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 10V3215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/22/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• 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
• Patient Outcome(s): Other