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

Catalog Number 000000000000010120

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Code Available (3191)

Event Date 04/09/2014

Event Type  Injury  

Event Description

The customer reported that they observed clumping in the reservoir and collect bag during a mononuclear cell (mnc) collection procedure.Per the customer, high platelet count was observed during the procedure and the operator adjusted the anticoagulant (ac) ratio from 8:1to 9:1.Per physician order, heparin bolus was given to the donor due to the clumping.The donor is in healthy condition.The customer declined to provide patient's (donor's) identifier and weight.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of heparin bolus.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf showed access issues throughout the run.Clumping was not seen in the aim images, indicating that the clumps in the reservoir and collection bag possibly developed after the product was at that point in the circuit.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the disposable set was unavailable for return and investigation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A service call was performed.Service check and saline run verified proper operation of the optia.Root cause: the service call and rdf analysis did not reveal a definitive root cause.The likely cause for the clumping is related to the donor's high platelet count.

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: 3787864
• MDR Text Key: 19584598
• Report Number: 1722028-2014-00158
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2014

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: 02/01/2016
• Device Catalogue Number: 000000000000010120
• Device Lot Number: 02W3226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/30/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• 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): Required Intervention
• Patient Age: 00071 YR