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

Model Number 10220

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported "cells detected in plasma line" alarms during an exchange procedure on a spectra optia device and the doctor pulled samples.Upon testing those samples, hemolysis was confirmed.Per the customer the solutions were correctly attached and hemolysis was observed in the channel midway through the procedure.Patient outcome and information is unknown at this time.The collection 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 b.5, h.6 and h.10.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.

Event Description

Tthe customer reported "cells detected in plasma line" alarms during an exchange procedure on a spectra optia device and the doctor pulled samples.Upon testing those samples, hemolysis was confirmed.Per the customer the solutions were correctly attached and hemolysis was observed in the channel midway through the procedure.Patient outcome and information are not available.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer noted that the occurrence of ¿cells were detected in plasma line from centrifuge¿ alarms was more frequent in single needle than dual needle rbcx procedures.During the investigation no complaints from other customers using sn rbcx were recorded.Terumo carried out internal testing on the single needle kit at the limits of the system and was unable to recreate the issue.No other customers are experiencing this issue with terumo¿s single needle connector.No other customers using these lots reported the issue.A 90-degree extension piece was tested running bovine blood (used the max inlet flow rate and pushed the limits during testing) and there were no signs of hemolysis.Disposables lot history: a disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Root cause: based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: * hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.* hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.* hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.* hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.* patient's underlying disease state.* patient's medication and/or medical treatment.

Event Description

Tthe customer reported "cells detected in plasma line" alarms during an exchange procedure on a spectra optia device and the doctor pulled samples.Upon testing those samples, hemolysis was confirmed.Per the customer the solutions were correctly attached and hemolysis was observed in the channel midway through the procedure.The customer did not respond to multiple attempts to obtain patient outcome and information.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12001094
• MDR Text Key: 261944255
• Report Number: 1722028-2021-00214
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

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: 02/02/2023
• Device Model Number: 10220
• Device Catalogue Number: 12220
• Device Lot Number: 2102043330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 12/06/2022; 02/25/2023
• Supplement Dates FDA Received: 12/16/2022; 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2021
• 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): Required Intervention; Other