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

Catalog Number 10220

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: per the customer, the operator performed custom prime.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure on apediatric patient, using a spectra optia device, they noted a pink tinge in the plasma that they described as hemolysis.The customer stated that they observed red blood cells passing into the plasma bag with pink colored plasma in the connector and waste bag, and there were no alarms.The customer contacted a terumo bct support specialist and stated that they observed changes in the interface, when the interface came up in the connector the buffy coat layer appeared to be pinkish.Tbct customer support suggested the operator to pause the procedure and to notify the physician.The operator confirmed that they checked the fluids and after notifying the physician a decision was made to resume the procedure as they were not able to identify the cause of the pink tinge in the connector or the presence of the red blood cells in the waste bag.Per the operator, the procedure resumed fine without any presence of pink tinge.Then, the customer noticed air in the lines coming out of the centrifuge with "chunks" in the red blood cells interface.The operator stopped the procedure.Per the customer, the patient is reported in the stable condition.The patient identifier (id) is not available at this time.The tpe 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 in event.Corrected information is providedin.Investigation is in process, a follow-up report will be provided.

Event Description

After multiple attempts for follow-up, the customer did not provide the lot number, additionalprocedural information and whether medical intevention was required.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.The customer did not provide the lot number pertaining to this event, therefore a device historyrecord (dhr) search could not be conducted for this specific incident.All lots must meetacceptance criteria before release.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: a definitive root cause of the observed red cells in the connector and plasma bagcould not be determined.Possible causes include, but are not limited to:- full or partial occlusion in the disposable set due to inadequate anticoagulation of theextracorporeal set.- operator performing blood prime using packed rbcs with high viscosity.

Event Description

The customer declined to provide the patient's id.No medical intervention was required forthis event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8612728
• MDR Text Key: 145537664
• Report Number: 1722028-2019-00113
• 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: 05/15/2019

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: 04/25/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 06/07/2019; 07/10/2019
• Supplement Dates FDA Received: 06/07/2019; 07/02/2019; 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00001 YR
• Patient Weight: 10