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 Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.There were no indications of air in the tubing set during the exchange and the return line air detector (rlad) did not trigger any alarms that indicate that air was in the tubing set up to the return pump at any point during the procedure.Terumo bct provided the customer the connecting and priming astotherm guide, which recommends ensuring a complete prime of the blood warmer tubing set to remove all the air in the set before connecting the patient.It is also recommended to ensure that the tubing connection between the blood warmer and the return line is tight and to put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.The lot number and expiry information was not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a pediatric patient with anti¿glomerular basement membrane(anti-gbm) antibody disease was undergoing a therapeutic plasma exchange (tpe) procedure on spectra optia.During rinse back, the operator observed air in the blood warmer tubing.It was reported by the customer that the patient did not receive any air and the procedure was terminated when the air was noticed.Per the customer, no return air line detector (rlad) alarms occurred during the procedure.The patient did not require medical intervention and is reported as stable.The customer declined to provide patient identifier (id).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 initial reporter occupation, device manufacture date, and evaluation codes.Corrected information is provided in model #, serial #, expiration date, catalog #, lot #, other #, udi # and pma/510k.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: based on the clinical findings and run data analysis, which confirmed there were norlad alarms indicating air was distal to the rlad, the air in the blood warmer tubing was due to outgassing of the cold saline used for rinseback as it passed through the warmer in the returnline.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8488302
• MDR Text Key: 146196157
• Report Number: 1722028-2019-00089
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K181049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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 Expiration Date: 01/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1901233330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00007 YR
• Patient Weight: 33