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 11/13/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that clots were noted in the return line during rinseback of the procedure.Per the customer, no alarms were given by the machine.Patient information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf confirmed that the spectra optia system operated as intended.The interface images in the rdf were reviewed and no clumping was observed in the channel throughout the run.A preventive maintenance was completed by a terumo bct service technician.The service technician was unable to confirm the reported condition.A review of the last year of service history for this device indicated no other reports related tot his issue.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of the clots in the return line reported by the customer could not be definitively determined.The service technician was unable to confirm the reported condition and found the machine to be operating with specification.The rdf analysis was unable to confirm clumping and showed that the system operated as intended.

Event Description

The customer declined to provide patient identifier and age.The patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5273979
• MDR Text Key: 33013273
• Report Number: 1722028-2015-00640
• 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
• Report Date: 12/08/2015

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 Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84