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

Model Number 61000

Device Problems Occlusion Within Device (1423); Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct technician evaluated the spectra optia machine and was able to duplicate the reported condition.The technician found the aim system was failing due to a defective firewire circuit card assembly (cca).The firewire cca was replaced an aim start up test was successfully completed.The technician also replaced the control stack and verified the rlad was functioning per manufacturer's specification.Investigation is still in process.A follow-up report will be provided.

Event Description

The customer reported that during a demonstration procedural run on a spectra optia machine, they received multiple alarms including the 'return air line detector' (rlad) alarm.No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information in initial reporter.Investigation is in process.A follow-up report will be provided.

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 did not show any alarms present.The machine started power fail shutdown sequence 3 minutes into the run.It could not be confirmed if the rlad would have failed safe.A internal report indicates no further related issues have been reported for this device.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the last year of service history for this device indicated no other reports related to this issue.Since the replacement of the control stack has resolved the rlad issue, it is likely that this part was defective or a contributing factor.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6440086
• MDR Text Key: 71248732
• Report Number: 1722028-2017-00099
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2017

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: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2017; 05/12/2017; 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other