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

Model Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Hemolysis (1886)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The customer reported a occurrence of hemolysis after removed plasma from 400 ml of treated plasma following a spse procedure.Per the customer, no serious injury occurred and no medical intervention was required for this event.Patient (donor) information and outcome are not available at this time.

Manufacturer Narrative

Investigation: the customer returned a used optia exchange set to terumo bct for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a occurrence of hemolysis after removed plasma from 400 ml of treated plasma following a spse procedure.Per the customer, no serious injury occurred and no medical intervention was required for this event.Patient (donor) identifier is not available at this time.Per the customer the there was no follow up needed for the complication.

Manufacturer Narrative

Investigation: the customer returned a used optia exchange set to terumo bct for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.Per the customer the hemolysis occurred in the plasma hose/connector after 21 minutes of treatment.The device alarmed "cells were detected in the plasma tube coming from the centrifuge".Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a occurrence of hemolysis after removed plasma from 400 ml of treated plasma following a spse procedure.Per the customer, no serious injury occurred and no medical intervention was required for this event.Patient (donor) identifier is not available at this time.Per the customer the there was no follow up needed for the complication.

Manufacturer Narrative

Investigation: the customer returned a used optia exchange set to terumo bct for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.Per the customer the hemolysis occurred in the plasma hose/connector after 21 minutes of treatment.The device alarmed "cells were detected in the plasma tube coming from the centrifuge".A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer returned a used optia exchange set for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.Review of the dlogs associated with this complaint does not indicate a conclusive root cause for the ¿cells were detected in plasma line from centrifuge¿.This alarm may occur if there is an air bubble stuck in the rbc detector, if there is an inaccurate entry of the patient hct, and possibly if hemolysis is present.The ¿cells were detected in plasma line from centrifuge¿ alarm occurs when the concentration of cells in the plasma line is higher than expected.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during the procedure.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, clumping in the set or issues with the rbc detector.The operator did attempt to adjust the patient hematocrit per the recommendations from the alarm screen; however, this did not help clear the alarm.Increasing the patient hematocrit would only help if the patient¿s hematocrit was entered too low and the interface was not properly set up.There were no apparent issues in the dlog or procedure that would indicate a reason for the alarm.If the alarm was indeed caused by hemolysis, it is not clear as to what may have caused hemolysis during this procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a occurrence of hemolysis after removed plasma from 400 ml of treated plasma following a spse procedure.Per the customer, no serious injury occurred and no medical intervention was required for this event.Pursuant to eu personal data privacy laws, the patient identifier is not available.Per the customer the there was no follow up needed for the complication.

Manufacturer Narrative

Investigation: the customer returned a used optia exchange set to terumo bct for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.Per the customer the hemolysis occurred in the plasma hose/connector after 21 minutes of treatment.The device alarmed "cells were detected in the plasma tube coming from the centrifuge".A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer returned a used optia exchange set for investigation.The presence of blood was noted in the inlet lines, cassette, channel, collect lines and reservoir.The saline/ac lines were rf sealed below the drip chambers.The waste bag was not returned for investigation.A witness mark located on the lower hex indicated the set was loaded optimally in the centrifuge.The set was flow tested and no flow restrictions were identified.In summary, no disposable defects were identified.The run data file (rdf) was analyzed for this event.Review of the dlogs associated with this complaint does not indicate a conclusive root cause for the ¿cells were detected in plasma line from centrifuge¿.This alarm may occur if there is an air bubble stuck in the rbc detector, if there is an inaccurate entry of the patient hct, and possibly if hemolysis is present.The ¿cells were detected in plasma line from centrifuge¿ alarm occurs when the concentration of cells in the plasma line is higher than expected.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during the procedure.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, clumping in the set or issues with the rbc detector.The operator did attempt to adjust the patient hematocrit per the recommendations from the alarm screen; however, this did not help clear the alarm.Increasing the patient hematocrit would only help if the patient¿s hematocrit was entered too low and the interface was not properly set up.There were no apparent issues in the dlog or procedure that would indicate a reason for the alarm.If the alarm was indeed caused by hemolysis, it is not clear as to what may have caused hemolysis during this procedure.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: an issue with the patient's catheter.Patient's underlying disease state.Patient's medication and/or medical treatment.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 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.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.

• 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: 13592286
• MDR Text Key: 288997795
• Report Number: 1722028-2022-00061
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2022

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: 11/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2111123230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/21/2022; 11/21/2022; 02/14/2023
• Supplement Dates FDA Received: 04/14/2022; 12/12/2022; 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2021
• 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): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 85 KG