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

Catalog Number 4122201

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

Patient Problem Hemolysis (1886)

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.The technician performed a successful autotest.The technician performed occlusion testing for pump rotors and pressure sensor verification successfully.Red blood cell detector verification was performed with no issues and the technician could not duplicate any errors.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure cells were detected in the plasma line in centrifuge.The color of the plasma in the connector was dark and occurred about 30 min into the run.The customer disabled aim and the alarm continued at which point she did a rinse back on the machine.Patient id is unknown at this time.Patient in stable condition the collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.The technician performed a successful autotest.The technician performed occlusion testing for pump rotors and pressure sensor verification successfully.Red blood cell detector verification was performed with no issues and the technician could not duplicate any errors.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.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

The customer reported that during a therapeutic plasma exchange (tpe) procedure cells were detected in the plasma line in centrifuge.The color of the plasma in the connector was dark and occurred about 30 min into the run.The customer disabled aim and the alarm continued at which point she did a rinse back on the machine.After multiple follow-up attempts, patient id was not provided by the customer.Patient in stable condition 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
• MDR Report Key: 18312715
• MDR Text Key: 330299131
• Report Number: 1722028-2023-00412
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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
• Report Date: 12/12/2023

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: 4122201
• Device Lot Number: 2308153141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 63 KG