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

Catalog Number 000000000000010120

Device Problem Fluid/Blood Leak (1250)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 01/07/2014

Event Type  Injury  

Event Description

The customer reported that a pediatric patient experienced platelet loss over the course of four mononuclear cell (mnc) collection procedures that were done on (b)(6) 2014.The morning before the fourth collection on (b)(6) 2014, the patient developed a nose bleed and a small bruise on the left scalp.The attending nurse ordered a platelet transfusion to the patient.The patient received 150mls of platelets before the procedure and a 108-mls platelet transfusion after the procedure.The current condition of the patient is not known at this time.Patient's identifier and age are not available at this time.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to platelet loss and medical intervention via platelet transfusions.

Event Description

The patient's identifier and age remain unavailable at this time.

Manufacturer Narrative

Investigation: per the customer, 3 different optia machines were used for the mnc procedures.The run data files (rdfs) were reviewed for this event.Per the rdfs, the machine worked as intended.17% platelet loss per tbv processed was noted for the procedures, which is within specifications for the device.The procedures that were run were long, with 16 tbvs processed overall.Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and analysis.The run data file was analyzed and showed that the procedures were long and processed many tbvs which can lead to good yield but also loss of platelets over a number of procedures.A review of the lot for similar reports was carried out, none have been reported.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.The run data files show that the system operated as intended and the platelet loss over the four runs is likely related to the multiple total blood volumes (tbv)s processed over this time period.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury.This supplement is being filed to modify information per fda request.

• 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: 3616661
• MDR Text Key: 4170615
• Report Number: 1722028-2014-00043
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120012
• 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: 01/15/2014

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: 11/01/2015
• Device Catalogue Number: 000000000000010120
• Device Lot Number: 11V3120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 02/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/07/2014; 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• 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; Required Intervention
• Patient Weight: 16