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

Model Number 61000

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

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4): maintenance review investigation: a terumo bct service technician visited the customer's site and machine checkout was performed.The service technician was able to duplicate the reported condition.The machine was connected with sts and it was noted that the return air detector was reading fluid all the time.The ribbon cable coming from the rlad was moved and it was noted that the status would change to air detected back to fluid detected.The upper and lower strobe cca's were replaced.The rlad was also replaced per manufacturing specifications.An autotest was successfully performed.One year of service history was reviewed for this device with no problems identified related to the reported condition.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during setup for a collection procedure, they received multiple 'return line air detector detected fluid too soon' alarms.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.Investigation: the device serial number history report indicates no further related issues have been reported for this device.The run data file (rdf) was analyzed for this event.The reported condition was verified in the rdf.Root cause: since the replacement of the rlad (return line air detector) has resolved the 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: 7122256
• MDR Text Key: 96011058
• Report Number: 1722028-2017-00486
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• 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: 12/15/2017

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: 11/21/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other