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

Model Number 61000

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service call was placed and a machine checkout was performed.The service technician visually inspected the return line air detector (rlad) and observed some buildup.Theservice technician cleaned the rlad and successfully performed a functional test on the rlad.The machine was returned to service.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported at the beginning of a therapeutic plasma exchange (tpe) procedure,they received multiple 'replacement fluid detector detected fluid too soon' alarms.Thecustomer stated that she cleaned the sensor, however, the alarms continued.Patient information is not available at this time.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The run data file (rdf) was analyzed for this event.The rdf analysis confirmed that the 'replacement fluid detector detected fluid too soon' alarm is a device failed safe alarm.Further clarification was received from the service technician and determined that the service technician inadvertently stated that the rlad was visually inspected instead of the replacement fluid sensor.The service technician clarified that a service call was placed and a machine checkout was performed in december 2017.The technician visually inspected the replacement fluid sensor and observed buildup.The service technician cleaned the replacement fluid sensor and successfully performed a functional test.The machine was returned to service.One year of service history was reviewed for this device with no problems identified related to the reported condition.The device serial number history report indicates no further related issues have been reported for this device.Root cause: the root cause of the reported 'replacement fluid detector detected fluid too soon' alarm was due to a dirty replacement fluid sensor.The device failed safe with an alarm and alarmed as designed.

Event Description

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 and corrected information.

• 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: 7154105
• MDR Text Key: 96127440
• Report Number: 1722028-2017-00523
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• 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: 12/29/2017

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: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 03/12/2018; 04/05/2018
• Supplement Dates FDA Received: 03/13/2018; 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other