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

Catalog Number 12220

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

Patient Problems Headache (1880); Nausea (1970); Tachycardia (2095)

Event Date 05/09/2023

Event Type  Injury  

Event Description

The customer reported to terumo bct customer support that during 2 treatments with a spectra optia device the blood gas analysis (bga) shows a clear hemoconcentration of the blood.This report is for the first event.Medical intervention given in iv fluid administration of 200ml sterofundin ordered by the dialysis doctor.The collection set is not available for return because it was discarded by the customer.The patient id is unknown.The patient is normal condition, no permanent damage.

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the customer, the replacement fluid was albumin (4% solution).Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: per the customer, the replacement fluid was albumin (4% solution).The run data file (rdf) was analyzed for this event.Review of the run data file and aim images for the 2 tpe procedures performed on this patient did not indicate a conclusive root cause for the reported higher than expected patient hct values after the runs.Analysis confirmed that for both tpe procedures, only plasma was going by the rbc detector and entering the waste bag during the entire run.There were no reservoir level sensor alarms or other events during the runs that would indicate a fluid shift or imbalance.The chosen replacement fluid was saline/albumin with a 4% citrate content.The actual replacement fluid was confirmed to be albumin.The plasma volumes exchanged were 1.4 and 1.6 respectively for the two dates may 9 and 10th with the final fluid balance at 100% for both procedures.There were several ¿aim system could not establish target interface¿ alarms early in the runs however shortly after the entered patient hct was updated, these alarms did not recur.Rinseback was successfully performed for each procedure.According to therapeutic apheresis: a physician's handbook, apheresis procedure itself leads to both hemodynamic and dilutional changes.Those physiologic consequences may also result in adverse events for the patient.Another major category of physiologic responses to therapeutic apheresis is fluid shifts that occur as whole blood is removed, as one or another component is retained, and as the remaining components are returned with or without replacement solution.Resultant changes in intravascular volume can induce hemodynamic alterations.Fluid overload (hypervolemia) may be a problem for patients with cardiac or renal impairment.In other situations, hypovolemia may be a concern.There is general sense that hemodynamic changes are more common with intermittent flow centrifugation than with continuous flow procedures.This situation probably relates to the greater extracorporeal volume associated with earlier models of intermittent flow machines.Therapeutic apheresis procedures may lead to major physiologic changes, including hypocalcemia caused by citrate infusion, hemodynamic changes associated with fluid shifts, and depletion of cellular and plasma constituents.As greater understanding of the physiology of apheresis has guided continued improvements in technology, the potential for untoward effects has been minimized so that procedures may usually be performed without adverse events.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a root cause assessment was performed for the increased in patient¿s post hematocrit and adverse reactions.A definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: the patient¿s underlying disease state , loss or inadequate replacement of proteins during the procedure , dehydration due to renal causes during the procedure , increased vascular permeability during the procedure , use of a blood gas analyzer to obtain the hct/hgb resulting in some variability in the values.

Event Description

The customer reported to terumo bct customer support that during 2 treatments with a spectra optia device the blood gas analysis (bga) shows a clear hemoconcentration of the blood.This report is for the first event.Medical intervention given in iv fluid administration of 200ml sterofundin ordered by the dialysis doctor.The collection set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient identifier is not available from the customer.The patient is normal condition, no permanent damage.

• 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: 17837121
• MDR Text Key: 324513236
• Report Number: 1722028-2023-00323
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 70 KG