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

Model Number 61000

Device Problems Incorrect Measurement (1383); Output Problem (3005); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure using a spectra optia device, they received the alarm 'hypovolemia limit was exceeded' and the machine stopped.The customer stated that the volume numbers on the screen were not accurate.The operator turned off the machine and was not able to continue.The operator attempted to perform rinseback, but the machine did not continue.The terumo bct clinical specialist walked the customer through a manual rinseback.The customer was able to estimate that approximately two and a half bottles of albumin had been given during the run.Patient information and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: the run data file (rdf) for this run is unavailable at this time.The rdf after the procedure was available.It indicates the occurrence of the 'hypovolemia limit was exceeded' alarm.This alarm occurs if the control stack has determined that the configured hypovolemia limit has been exceeded.On screen recommendations indicate to discontinue the procedure.The operator likely was unable to perform rinseback due to the procedure.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide corrected information in d.1, d.2, d.3, d.4, g.4, h.4, h.5, h.8 and additional information in h.6, h.10.Investigation: the device serial number history report indicates there was an additional report of a similar issue.The issue was not reportable to the fda.Investigation is in process.A follow up report will be provided.

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.Final fluid balance of the patient was found to be within acceptable limits.Service was sent on site.Review of the run data files shows outofreplacefluid followed by high level too late alarms.Service ran a complete autotest and a simulated run for 10 minutes without failure.The run data file for this procedure was analyzed.Review of the run data file shows fluid balance was at -77ml (98%) for a patient with a tbv of 5076ml.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10 root cause: the root cause of this failure was due to a known software issue.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10792765
• MDR Text Key: 216859046
• Report Number: 1722028-2020-00497
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2020

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
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 03/30/2021; 11/19/2021; 05/26/2022
• Supplement Dates FDA Received: 12/18/2020; 04/08/2021; 12/03/2021; 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other