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

Catalog Number 12220

Device Problems Coagulation in Device or Device Ingredient (1096); No Apparent Adverse Event (3189)

Patient Problems Hemolysis (1886); No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was reviewed for this event.Review of the rdf confirms the occurrences of the ¿cells were detected in plasma line from centrifuge¿ alarms and ¿system continued to detect cells in plasma line from centrifuge¿ alarms throughout the procedure.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during procedures.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, hemolysis and or clumping or issues with the rbc detector.Review of the equipment showed that the aperture plate was dirty and cloudy and should be replaced.A dirty aperture plate can cause the lighting to diffuse differently and can cause these alarms.The operator did attempt to adjust the patient hematocrit per the recommendations from the alarm screen; however, in two of these procedures the operator decreased the hematocrit.Decreasing the hematocrit too much can cause the interface to be too high and increase the occurrence of this alarm.In the alarm screen the recommendations are to increase the hct.Increasing the patient hematocrit would only help if the patient¿s hematocrit was entered too low and the interface was not properly set up.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during an exchange procedure using a spectra optia device, hemolysis occurred after 194ml of plasma had been processed.Per the customer they decided to end the procedure and start again with a new set.Patient identifier and age are not available at this time.Terumo bct is awaiting return of the disposable set.

Event Description

Pursuant to european union general data protection regulation 2016/679 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, the patient identifier and age are not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.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.It was determined that hemolysis did not occur.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, and corrected information in h.6.Root cause: a definitive root cause for the reported hemolysis could not be determined.Review of the dlogs associated with these complaints confirms the occurrences of the ¿cells were detected in plasma line from centrifuge¿ alarms and ¿system continued to detect cells in plasma line from centrifuge¿ alarms throughout the procedures.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during procedures.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, hemolysis and or clumping or issues with the rbc detector.Review of the equipment showed that the aperture plate was dirty and cloudy and should be replaced.A dirty aperture plate can cause the lighting to diffuse differently and can cause these alarms.The operator did attempt to adjust the patient hematocrit per the recommendations from the alarm screen; however, in two of these procedures the operator decreased the hematocrit.Decreasing the hematocrit too much can cause the interface to be too high and increase the occurrence of this alarm.In the alarm screen the recommendations are to increase the hct.Increasing the patient hematocrit would only help if the patient¿s hematocrit was entered too low and the interface was not properly set up.

Manufacturer Narrative

This report is being filed to provide additional information in h.3, h.6 and h.10 and corrected information in d.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr.The disposable set was not available for return.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: 10033310
• MDR Text Key: 196390901
• Report Number: 1722028-2020-00209
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2001033230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 06/18/2020; 06/24/2020; 07/21/2020
• Supplement Dates FDA Received: 06/22/2020; 07/14/2020; 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77