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

Catalog Number 10220

Device Problems Infusion or Flow Problem (2964); Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)

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

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported hemolysis during therapeutic plasma exchange (tpe) on three different procedures on a covid-19 positive patient with hypercoagulopathies.For the patient, there were microaggregates resulting in plasma hyperviscosity, with difficulty to maintain flow rates on the optia.The customer experienced blood component separation in the channel and they were unable to maintain inlet flow rate >30ml/min with persistent red blood cell (rbc) detector alarms.This report is for the second of the three procedures.Per the customer, there was no serious injury and no medical intervention was required for this event.Patient information is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Per the investigation, there is no concern for hemolysis for this event.The device history record was reviewed for this lot.There were no issues noted that would have contributed to the hemolysis experienced by the customer.The run data file was analyzed for this event.The run data file was analyzed for this event.Review of the run data file (rdf) and aim images associated with this procedure did not show a conclusive root cause for the reported interface issues experienced during the procedure.The run met the targeted values of plasma volume replaced of 4500ml of respectively.It is suspected that possible issues seen during the procedure was likely related to the patient¿s disease state with mitigating factors that include inaccurate patient hematocrit data entered, inlet:ac ratio values and inlet flow rates possibly set too high for this patient.Review of the run data file did indicate a successful collection.Although there no alarms, images confirmed that the interface was higher than expected in the connector which may have been a result of lower hematocrit values being entered into the system.If looking into the viewport, the interface is close to the top of the connector, it may be helpful to increase the hematocrit value by 3 percentage points.This will lower the interface which can help to optimize the collection and prevent cells from entering the plasma line.The run had high inlet flow rates with most of the procedure at the maximum flow rate of 142ml/min.It is recommended to enter a rate that allows a steady flow rate and is least likely to cause a pressure alarm.The inlet flow rate is directly related to the centrifuge speed and, therefore, affects the packing factor.Decreasing the inlet pump flow rate will increase the packing factor which can allow for optimal separation of cells and decrease turbulence in the connector if present.This can be especially helpful if the patient¿s blood physiology or cell morphology is suspected to contribute to abnormal separation of the blood.The inlet:ac ratio for this procedure was set at 14 and not changed throughout the run.The default value is 10 as this value works for most procedures however it can be increased if adequate anticoagulation is maintained.For some patients, entering a lower value initially then increasing it later in the procedure may be beneficial.If a higher value is used, the system should be monitored for clumping in the channel and consideration of its effect on the procedure.The customer provided several photographs relating to the 3 tpe procedures carried out.Visual examination of the photos of the remove bags revealed the presence of rbcs in plasma.The photos confirmed there was separation of the blood components.A lot history search confirmed there were no similar occurrences on lot 1912033130 reported worldwide.Investigation is in process.A follow up report will be provided.

Event Description

Per the customer, the same patient was treated with tpe using membrane technology following these events and they did not have any coagulation issues.They used prismaflex with predilution.The hospital icu continues to treat many covid19 positive patients on optia devices with no further complications.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow up report will be provided.

Event Description

The customer decline to provide patient identifier and age due to privacy concerns.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h10.Root cause: a definitive root cause for the rbc spillover could not be determined.Review of the above two rdfs and aim images associated with these procedures from the 3rd and 5th june did not show a conclusive root cause for the reported interface issues experienced during the procedures.Both runs met the targeted values of plasma volume replaced of 3500ml and 4500ml respectively.It is suspected that possible issues seen during the procedures were likely related to the patient¿s disease state with mitigating factors that include inaccurate patient hematocrit data entered, inlet:ac ratio values and inlet flow rates possibly set too high for this patient.Review of the run data files did indicate a successful collection for both procedures.Although there no alarms, images confirmed that the interface was higher than expected in the connector which may have been a result of lower hematocrit values being entered into the system.If looking into the viewport, the interface is close to the top of the connector, it may be helpful to increase the hematocrit value by 3 percentage points.This will lower the interface which can help to optimize the collection and prevent cells from entering the plasma line.Both runs had high inlet flow rates with most of the procedure at the maximum flow rate of 142ml/min.It is recommended to enter a rate that allows a steady flow rate and is least likely to cause a pressure alarm.The inlet flow rate is directly related to the centrifuge speed and, therefore, affects the packing factor.Decreasing the inlet pump flow rate will increase the packing factor which can allow for optimal separation of cells and decrease turbulence in the connector if present.This can be especially helpful if the patient¿s blood physiology or cell morphology is suspected to contribute to abnormal separation of the blood.The inlet:ac ratio for these procedures was set at 14 and not changed throughout the runs.The default value is 10 as this value works for most procedures however it can be increased if adequate anticoagulation is maintained.For some patients, entering a lower value initially then increasing it later in the procedure may be beneficial.If a higher value is used, the system should be monitored for clumping in the channel and consideration of its effect on the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10218012
• MDR Text Key: 200619217
• Report Number: 1722028-2020-00318
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1912033130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70