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

Catalog Number 12220

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Chills (2191); Reaction (2414)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals show clear plasma in the plasma line in the beginning of the run.Approximately 25 minutes into the procedure the fluid flowing through the plasma line starts to become less clear and the device alarmed with, "cells were detected in plasma line from centrifuge" at 35 minutes.The signals from the rbc detector were normal and did show the fluid becoming darker.The rbc detector performed according to specifications and was acting normally.The signals in the rdf indicate that the spectra optia system operated as intended.A terumo bct service technician checked out the machine at the customer site.The technician verified all pressure transducers and found all to be within manufacturers specification.The technician also verified rotor occlusion on pumps 4 and 5.An auto test and saline run while verifying all alarms were successfully completed.Machine meets all manufacturers specifications.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported during an exchange procedure on a spectra optia device on a sickle cell patient they received a 'cells detected in the plasma line from the centrifuge' alarm.Per the customer the depletion portion was completed and was on her 2nd unit of blood during the exchange when the alarm was reported.They hadn't been able to clear the alarm by increasing the hematocrit of the unit of blood.Per the customer the plasma was described as being brown, and there was a clear separation of the plasma and red cells in the connector.Per the customer this patient has previously been treated before in the past and not had this issue.Terumo bct customer support had her to confirm correct fluids hanging on appropriate lines.Pause the procedure and start a slow saline drip to the patient and call the physician.The customer was told to call back once she got the ok to continue with the procedure from the physician.The customer called back and informed that the physician said it was ok to continue.They did not indicate if the discolored plasma was due to the patient disease process.The customer was instructed by customer support through disabling the rbc detector.It was explained how she needed to monitor the interface and gathered additional information.Customer support had her look at the interface after the system had started back exchanging plasma.Per the customer the entire interface was red.The customer provided pictures.The 1st picture reflect a pinkish red plasma and 2nd picture the rbc layer below the plasma is visible.Customer support instructed to pause the procedure again and told her to call the physician back with the change in the plasma color.Per customer support, it could be the 2nd unit of blood causing the plasma to turn this color.Due to the additional change, the physician needed to be notified before continuing with the run.Upon follow-up with the customer, the customer reported the physician indicated it may have been a transfusion reaction.They discontinued the procedure and started a transfusion reaction protocol.After they stopped the procedure the patient had chills and dyspnea.The customer provided the following medical intervention: tylenol 650 mg, po, benadryl 25 mg ivp, hydrocortisone 100 mg ivp, 500 ml ns bolus.Blood cultures & urinalysis done.On follow-up in 11/15, there was a noted reported from the physician stating "per blood bank, no evidence of hemolytic transfusion reaction noted." per the customer, the patient is stable now and just "hanging out" in the unit.The customer declined to provide the patient identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Updated investigation: the run data file (rdf) was analyzed for this event.The signals show clear plasma in the plasma line in the beginning of the run.Approximately 25 minutes into the procedure the fluid flowing through the plasma line starts to become less clear and the device alarmed with, "cells were detected in plasma line from centrifuge" at 35 minutes.The signals from the rbc detector were normal and did show the fluid becoming darker.The rbc detector performed according to specifications and was acting normally.The signals in the rdf indicate that the spectra optia system operated as intended and there was no indication the device contributed to the reported hemolysis.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in e.3.Investigation: a disposable history search for lot 1908273230 found no other reports of similar issues.Root cause: a definitive root cause of the discolored plasma could not be determined.Possible causes include but are not limited to: the patient's underlying disease state; an occlusion in the disposable set due to a misload or unidentified manufacturing defect; use of viscous replacement fluid (red blood cells).- use of expired replacement fluid (red blood cells).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9376482
• MDR Text Key: 185231436
• Report Number: 1722028-2019-00380
• 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,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1908273230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 01/20/2020
• Supplement Dates FDA Received: 01/10/2020; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00033 YR
• Patient Weight: 102