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

Catalog Number 10316

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An adverse event was reported related to a clinical study on white blood cell depletion (wbcd) using a spectra optia device.An increased ldh was reported in the patient.The patient was given methylprednisolone sodium succinate needle and calcium gluconate injection.The patient was reported as recovered.Patient age, weight, and gender are not available at this time.The disposable set is not available for return because it was discarded by the customer this product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The specific ldh result was not provided.In addition to increased ldh, test results indicated the subject had hypoalbuminemia and a decreased platelet count.Patient¿s gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The operator made no changes to the default packing factor or collect pump flow rate, and there were no excessive pump pauses during the run.No signs of aggregation were observed in the aim images.The collection preference (cp) varied from 65-78 for throughout the procedure.Lactic acid dehydrogenase (ldh) is an enzyme that helps produce energy.If ldh blood or fluid levels are high, it may mean certain tissues have been damaged by disease or injury.A normal ldh range in adults (blood) is 140-280 u/l.Disorders that cause high ldh levels include: anemia, kidney disease, liver disease, muscle injury, heart attack, pancreatitis, infections, including meningitis, encephalitis, and infectious mononucleosis (mono), and certain types of cancer, including lymphoma and leukemia.A higher than normal ldh level may also mean treatment for cancer is not working.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

Investigation: a disposable history search of the lot number found no other reports of increased ldh levels.Per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: the specific root cause for the increase in ldh could not be determined.Based on literature and medical review, the increased ldh is likely related to the patient's disease progression.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10779122
• MDR Text Key: 214397369
• Report Number: 1722028-2020-00492
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

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: 02/01/2021
• Device Catalogue Number: 10316
• Device Lot Number: 1902083130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 03/05/2021; 05/03/2021
• Supplement Dates FDA Received: 03/17/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 72