MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Aterumo bct service technician was unable to duplicate the reported condition.A functional checkout of the machine was performed and all functional tests met specifications.All pressure sensors were verified per manufacturer's specification with no issues noted.An auto test and saline run was successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure, they observed clotting in the returnline.Patient information is not available at this time.Patient outcome is not available at this time.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that there were no return pressure was too high alarms to indicate that there was any restriction of flow in the return line and there were no air detected in the return line alarms.Aim images were reviewed for signs of possible clumping in the channel.No clumping in the channel was observed.Based on the information in the rdf, the spectra optia system operated as intended.One year of service history was reviewed for this device with no problems identified related to the reported condition.A device history report indicates a similar failure occurred in (b)(6) 2015.Root cause: the root cause of the clots in the return line reported by the customer could not be definitively determined.Based on the machine checkout and the rdf analysis, the pressure sensors were within specifications and the system operated as intended.

Event Description

Patient identifier and age are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

The customer declined to provide patient identifier and age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5174721
• MDR Text Key: 29259460
• Report Number: 1722028-2015-00597
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2016; 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75