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); No Apparent Adverse Event (3189)

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

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: 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.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that after approximately 180ml of plasma had been processed during an exchange procedure using a spectra optia device, hemolysis occurred.Hemolysis had been excluded from the patient prior to the procedure, and the patient comes to treatment regularly with no previous hemolysis events.Per the customer the procedure was ended.Patient id, age and outcome are not available at this time.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Corrected information is provided in b.6.Investigation: the run data file (rdf) was analyzed 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 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 images shows that the aperture plate may be a little dirty and likely needs to be replaced.Although this may not be the definitive reasons for the alarms, it can contribute.Review of the images also shows the interface is high in some of the procedures.Ensure the correct patient hematocrit is entered for this procedure.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: 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.

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

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr.Investigation is in process.A follow up report will be provided.

Event Description

The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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 images shows that the aperture plate may be a little dirty and likely needs to be replaced.Although this may not be the definitive reasons for the alarms, it can contribute.Review of the images also shows the interface is high in some of the procedures.Ensure the correct patient hematocrit is entered for this procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10034211
• MDR Text Key: 200626160
• Report Number: 1722028-2020-00213
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2002053230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00056 YR
• Patient Weight: 88