MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 4122201

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Event Description

The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure there was a "cells were detected in plasma line from centrifuge" alarm and the operator noticed that the plasma lines were not fixed to the cassette.There was no reported injury and not medical intervention for this event.The patient id and age are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: reported calculated final fluid balance was 103%.The device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: reported calculated final fluid balance was 103%.The device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.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.It was confirmed that there was no concern for ac overinfusion for this event.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure there was a "cells were detected in plasma line from centrifuge" alarm and the operator noticed that the plasma lines were not fixed to the cassette.There was no reported injury and not medical intervention for this event.The patient id and age are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18427750
• MDR Text Key: 332603205
• Report Number: 1722028-2024-00002
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2305173141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2023
• 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
• Patient Sex: Female
• Patient Weight: 60 KG