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

Catalog Number 10220

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2019

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 air seen in the return line before a patient was connected for a single needle therapeutic plasma exchange (sn tpe) procedure on a spectra optia device.The air was observed in the line before connecting it to the patient and the line was changed so that no air went to the patient.The customer's medical director requested the device be checked out before it is used again to ensure that the device did not cause the air.Per the customer, they did not see air in the cassette, the reservoir or the return line coming from the machine.The air was observed in the extension line they had connected.In addition, they also had blood warmer tubing, extension line, as well as the single needle adapter, and aline for calcium gluconate connected to the return line.Per the customer when the air was observed the calcium was removed.Per terumo bct customer support, it was discussed with the operator that as there was no air seen in the cassette, reservoir or return line of the original tubing set it would be more likely that the air was caused by either a connection or having too many tubes connected to the sn connector.There was not a patient involved at the time of the event, therefore no patient information is reasonably known at the time of the event.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.Corrected information is provided.Investigation: during follow-up with the customer, terumo bct clinical support discussed that a possible cause in this situation was the connections to the end of the return line or the sn adapter.The use of iv calcium on the return line in sn was also discussed and that there is a risk of recirculation during the draw phase, as anything in the line will be pulled in to the machine and this could potentially cause clumping and or clotting, as the role of the calcium is to bind with the acd-a and it will also do this in the system if pulled in during the draw phase.As there is no blood going back to the patient during this phase the calcium will be re circulated and follow the flow of blood.The customer was provided with the white paper from terumo bct for the spectra optia apheresis system concerning calcium infusion for the management of apheresis procedures.The customer did not respond to multiple attempts to obtain information for the investigation such as procedural details and lot information.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: a failure to fully prime the return line/single needle adapter/blood warmer tubing.A faulty luer connection between the return line and/or the blood warmer, extension, ca gluconate lines due to operator error or an unidentified manufacturing defect.

Event Description

Per the operator, they saw air in the line before connecting it to the patient and the line was changed so that no air went to the patient.It was reported that the patient remained in stable condition.After multiple attempts the patient identifier, age and weight were not provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9208698
• MDR Text Key: 190180989
• Report Number: 1722028-2019-00308
• 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): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD WARMER.
• Patient Outcome(s): Other