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

Catalog Number 12220

Device Problems Use of Device Problem (1670); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6): per the customer, the amount of air seen was approximately 0.1-0.2 mls.The customer was provided with support documentation after discussion with terumo bct medical liaison; a link to a medscape article is provided that states "the rapid ingress of large volumes of air 0.30 ml/kg/min) into the venous circulatory system can overwhelm the air-filtering capacity of the pulmonary vessels, resulting in a myriad of cellular changes."thus a single 0.2 ml of air would not pose a risk even for a very small patient.Also, terumo bct customer support provided a white paper on outgassing "outgassing with the use of a blood warmer in cobe spectra apheresis system or spectra optia apheresis system therapeutic apheresis procedures" - gaseous bubbles that are infused into human venous bloodat rates =0.10 ml/kg/min, then pulmonary dissipation mechanisms will be adequate to prevent embolization of the arterial circuit.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while performing validation test on spectra optia during priming foran exchange procedure they observed air in the return line at manifold and at needle injection site.Per the customer they tried to remove the air bubbles by flushing the line but it did not move.The customer contacted terumo bct for troubleshooting.The support specialist instructed the operator to discuss the bubble size with the physician at site and suggested to aspirate the bubble if it did not flush out.There was no donor connected for this event, therefore no donor information is reasonably known at the time of the event.The spectra optia exchange 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 and updated information is provided in the investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide investigation: during follow-up with the customer, it was reported that they saw the air afterpriming the return line.They starting using the sets and continue to see the air pocket and itdoesn't move.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the customer provided 3 pictures and a video to terumo bct to aid in the investigation.The pictures and video confirmed a small amount of air trapped in the area of the return line manifold at the needle injection site.The amount of air seen was 0.1 - 0.2 ml.Correction: information was provided to the customer regarding air in the return line manifold, no further retraining was required.Root cause: based on the information available, the air in the return manifold is due to inadequate priming of the return manifold during saline prime.As a result, a small air bubble was trapped in the needle injection site.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8981449
• MDR Text Key: 165079807
• Report Number: 1722028-2019-00258
• 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,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1905303330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other