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

Catalog Number 10220

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used optia set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.All witness and wear marks indicate individual loop and channel components were properly loaded.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per terumo bct clinical support, signals from the rbc detect or indicate that the hemolysis was present at the very beginning of the procedure.The red/green ratio indicates that the plasma flowing through the plasma line was not completely free of hemoglobin upon the start of the procedure.This hemolysis was already present and was not caused by the optia device.During follow-up with the customer, it was reported that the lab tested the first unit and there was some hemolysis and that she saw the dark plasma in 1st 10 min of the procedure.Not lab report was provided.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a patient with sickle cell zero thalassemia was undergoing a red blood cell exchange (rbcx) on a spectra optia device.Approximately 19 minutes into the procedure, they received an aim system detected rbc interface near top of channel alarm and observed hemolysis in the connector and plasma line that was dark yellow.Per the customer,the patient had been given about 225 ml of the 1st unit.It was reported that the operator paused the device and checked the fluids hanging.Per the customer the physician was notified of the event.Upon follow up with the customer the physician wanted to continue the procedure and send the unit that was hanging back to blood bank for testing.Before restarting the run, the operator checked the channel loading.The run was restarted, and it was reported that the plasma cleared up a little.The rbc was no longer floating up into the plasma layer.The procedure was continued, and the patient tolerated fine.The patient is reported in stable condition.

Manufacturer Narrative

Investigation: per the customer, the rbc unit expiration date was 9/21/2019.The procedure was performed on (b)(6) 2019.The run data file (rdf) was analyzed for this event.Review of the rdf associated with this complaint indicates the possibility that the patient related disease state or physiological blood characteristics may have caused the ¿aim system could not establish target interface¿ and the ¿aim system detected rbc interface near top of channel¿ alarms.The system generates the ¿aim system could not establish target interface¿ alarm when the system cannot establish the targeted interface within a set timeframe.As the first ¿aim system could not establish target interface¿ alarm appeared shortly after the procedure started it is likely that the patient¿s hematocrit was initially entered too high and/or the interface visibility challenges were a result of the presence of abnormally dark plasma that was observed in the aim images.The aim images for this procedure showed that the patient¿s plasma was very dark, to the point that it was almost indistinguishable from the red cell layer as the procedure continued.This in turn caused the system to interpret the rbc interface as being too high in the connector and triggered the ¿aim system detected rbc interface near top of channel¿ alarms.This alarm commonly occurs if the patient hematocrit entered was lower than actual, a shift in fluid balance caused the actual hematocrit to increase or in the case of hyper-viscosity, the blood is inhibited from properly separating which results in a portion of the cells being retained in the plasma.The cause of the patient¿s darker plasma is unknown; nevertheless, it is likely that the patient¿s blood physiology and/or cell morphology that contributed to the alarms generated by the system and visible color difference of the plasma in the set.Considering the combination of these signals, the cause of the issues and alarms in this procedure is most likely due to the specific physiological blood characteristics of the patient and not the device.Note if the said alarms occur are confirmed to be related to the abnormal blood physiology related to the patient condition, the aim system may be disabled.The operator should consult with the physician prior to disabling the aim system and continuing the procedure.The device operated as intended and the aim images were clean and clear and showed no signs of clumping or clotting.The pumps and level sensors were operating as intended and the pressures of the system were within normal operating range.Correction: customer acknowledged that unit tested was hemolyzed.No further retraining will be conducted by terumo bct.Root cause: based on the rdf analysis and aim images, the information concluded that there was hemolysis detected from the very beginning of the procedure.The root cause was determined to be that the customer used a unit of replacement rbcs that were found to be hemolyzed.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9110019
• MDR Text Key: 166190295
• Report Number: 1722028-2019-00278
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1907013230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00025 YR
• Patient Weight: 102