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

Catalog Number 10220

Device Problems Misassembled (1398); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: photographs were provided in lieu of the disposable set to aid investigation.The provided images show the inlet and return saline lines containing product.The return saline roller clamp is confirmed to be correctly assembled and in the closed position.However, the inlet saline roller clamp has not been correctly threaded with the tubing flossed over the roller wheel.This failure inhibits the closure of the inlet roller clamp.Correction: retraining of the manufacturing staff was completed on 12 oct 2020.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that when the operator opened the disposable tubing set they saw the inlet saline line went over the wheel of clamp, not through.The operator was forced use another clamp to close this line during disposable testing and then during the therapeutic plasma exchange (tpe) procedure while using a spectra optia device.Per the customer, there was no injury and no medical intervention was required for this event.The exchange set is not available for return because it was discarded by the customer.Patient information is unknown 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.It was determined that no hypervolemia occurred and the patient fluid balance was 100%.The run data files were analyzed for this event.There were no issues noted during the run and plasma expression values were normal.Investigation is in process.A follow up report will be provided.

Event Description

Upon follow up, the customer stated that the misassembly was noticed before prime, during tubing set test.No saline was used prior to noting the defect.Patient fluid balance was 100%.

Manufacturer Narrative

This report is being filed to provide additional information in e.3.Investigation is in process.A follow-up report will be provided.

Event Description

The customer did not respond to multiple attempts to obtain additional patient information.Only patient gender and weight were provided.

Manufacturer Narrative

This report is being filed to provide additional information in a.3, b.5, h.6 aand h.10 investigation : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause : the cause of the reported defect was related to a mis-assembly, where the assembler neglected to attach or install correctly a component to the set during manufacturing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10691042
• MDR Text Key: 213504682
• Report Number: 1722028-2020-00478
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2020

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 Expiration Date: 04/01/2022
• Device Catalogue Number: 10220
• Device Lot Number: 2004163230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 12/22/2020; 03/22/2021
• Supplement Dates FDA Received: 11/10/2020; 01/14/2021; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75