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

Catalog Number 10225

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: based on the current available information, it is unknown if air was observed in the return tubing past the last point of detection.Per the customer, passage of the caps without the machine lengthened the time of transfusion.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported after connecting the patient femorally for a procedure on the spectraoptia, the machine indicated a flow issue.Upon observation, air was observed in the disposable set.Per customer, the machine alarmed indicating inlet sensor error and the procedure was stopped.Due to eu personal data protection laws, the patient information and outcome is not available from the customer.The spectra optia disposable set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during 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 additional information.Investigation: during the investigation, it was determined that the customer likely tried to manipulate the needle or catheter and introduced air into the inlet line, resulting in them not being able to restart.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 the air in the inlet line cannot be returned to the patient in a red blood cell exchange (rbcx) procedure root cause: based on the available information, there is no clear root cause for the suspected air in the set.There was no indication if a blood warmer was being used for this procedure.There were no leaks reported in the set.The customer indicated that there was an issue with connection to the patient's femoral line and there was air in the disposable set.This was followed by an alarm, most likely 'inlet pressure was too low' alarm due to the obstruction in the inlet flow.A definite root cause for air in the disposable set could not be determined.Possible causes include but are not limited to:- the patient's femoral access was not properly positioned- poor connection between the catheter and the inlet luer.

Event Description

After multiple attempts, the machine serial number was not able to obtained from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8297127
• MDR Text Key: 137029593
• Report Number: 1722028-2019-00029
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 10225
• Device Lot Number: 04A3106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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