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

Model Number 000000000000061000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/20/2014

Event Type  malfunction  

Event Description

The customer reported that during prime for therapeutic plasma exchange (tpe) procedures, they received 'return line detected fluid too soon' alarms on two consecutive occasions from the same spectra optia machine.Patient information is not available per the customer.This report is being filed due to a device malfunction that has the potential for injury.

Manufacturer Narrative

Investigation: the machine was checked out at the customer site by a terumo bct service technician.The checkout was completed with no problems found.The rlad was found to be working normally.The machine was returned to service.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a voluntary medical device product was released by terumo bct and the rlad was upgraded to the new design on (b)(6) 2014.A review of seven different run data files was conducted, with run dates between (b)(6) 2014 and (b)(6) 2014.There was at least one occurrence of the detected fluid too soon alarms.There were no occurrences of the alarm in periods from (b)(6) and (b)(6) of 2014 or (b)(6) and (b)(6) 2014.An internal report shows that the machine has been in use with no further occurrences of the problem.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the last year of service history for this device indicated no other reports related to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Root cause: the root cause of the reported rlad alarms could not be determined given the information available.Several out of date circuit boards were replaced during service in (b)(6) 2015 and the rlad alarms stopped after that service, so the root cause is likely connected to those outdated components.Corrective action: an internal capa is in process for the optia control stack, optia motherboard, and optia top cap cca.

Event Description

No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

Manufacturer Narrative

Investigation: terumo bct's engineer visited the customer's site.Upon visual inspection and mechanical evaluation, several issues were found with obsolete circuit cards and fluid contamination of electronics.The control and safety stacks were upgraded, along with the top cap cca.The recently upgraded rlad was found to be functioning properly and was not replaced.A simulated use test was ran for approximately 2 hours and the reported alarm could not be duplicated.After the repairs, the optia machine operated with no issues.February and march run data files (rdf) were reviewed after this activity.A total of 49 runs were available for review and there were no rlad alarms of any type found in any of the records.Investigation is in-process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4266695
• MDR Text Key: 17694845
• Report Number: 1722028-2014-00470
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/27/2014

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 Model Number: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2015; 02/24/2015; 05/08/2015; 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2009
• 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