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

Catalog Number 12220

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the dlogsassociated with this complaint indicates the possibility that the patient related disease state 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 and persisted for the duration (167 minutes), 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.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 hyper-viscosity, the blood is inhibited from properly separating which results in a portion of the cells being retained in the plasma.The operator did adjust the entered hematocrit, as is recommended on the alarm screen; however, it had no noticeable effect on the perceived interface position because of the darker plasma/blood physiology.The cause of the dark plasma is undetermined at this time; nevertheless, it is likely that the patient¿s blood physiology and/or cell morphology contributed.Considering the combination of these signals, the cause of the issues and alarms in this procedure is most likely due to the disease state of the patient.Investigation is in process, a follow up report will be provided.

Event Description

The customer reported that hemolysis occured during procedure on spectra optia using secondary plasma device (spds) in combination with glucosorb.They also experienced 'aimcould not establish target interface' alarm and 'aim system detected rbc interface near top of channel alarm'.The customer stated they suspected that the hemolysis happened was due to the presence of kink in the return pump tubing.The spectra optia exchange set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient identifier (id), age and outcome information is not available from the customer.Patient's gender and weight information were obtained from the run data file (rdf).

Manufacturer Narrative

Root cause: the rdf information concluded that there were no return pressure alarms during the procedure to indicate occlusions or kink in the return pump header tubing.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 and persisted for the duration (167 minutes), 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 operator did adjust the entered hematocrit, as is recommended on the alarm screen; however, it had no noticeable effect on the perceived interface position because of the darker plasma/blood physiology.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 kit.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.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 was found to have functioned as intended.

Event Description

Per the customer no medical intervention was administered to the patient.

Manufacturer Narrative

This report is being filed to provide in investigation: per the customer, the patient is preparing for kidney transplant.A patient'sblood prior to a kidney transplant can be very viscous and hard to separate.Other factors includedrugs that patient is on, dialysis method and possibly physiological blood factors.The patient hadno disease state but had to do a abo treatment (column run) before kidney transplantation.A review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8600205
• MDR Text Key: 146413314
• Report Number: 1722028-2019-00109
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1901103130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70