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

Catalog Number 12220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: the machine was checked at the customer site by a terumo bct technician.Reservoir level sensor test, pressure test, occlusion test, aim system tests, autotest all passed.All aim lenses were cleaned and the smudged diffuser plate was replaced.Investigation is in process.A follow-up report will be provided.

Event Description

The customer contacted terumo bct and requested device service after a reported hemolysis event.Additional procedural details are not available at this time.Patient information and outcome is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf indicates the possibility of hemolysis during this procedure, as the first ¿cells were detected in plasma line from centrifuge¿ alarm appeared approximately 25 minutes into the procedure and persisted.The operator disabled the rbc detector during the procedure.The system generates this alarm when the rbc detector detects a red/green ratio greater than 1.5 during rbcx 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, or hemolysis may have occurred.The operator did not attempt to adjust the patient hematocrit per the recommendations from the alarm screen; increasing the patient hematocrit would only help if the patient¿s hematocrit was entered too low.The rdf does not point to a root cause.Additionally, the optia device was found to be operating as intended and the likelihood of disposable set defect contributing is low.This is evidenced by successful disposable prime as well as the lack of inlet, return, and centrifuge pressure alarms prior to the first ¿cells were detected in plasma line from centrifuge¿ alarms and for the duration of the procedure.It is possible the alarm occurred due to patient blood physiology and diagnosis.Investigation is in process.A follow up report will be provided.

Event Description

Per the customer the hemolysis was seen one hour into the procedure at the site of the connector.The customer's consultant stated that it was highly unlikely that the hemolysis was due to disease state or medication.Per the customer, the plasma was yellow; they deactivated the red blood cell detector because the return line only contained plasma.No medical intervention was necessary for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Updated investigation: a terumo bct service technician checked out the machine at the customer site on device 1p01432 on (b)(6) 2020.The diffuser plate was replaced.All pressure and occlusion testing were completed and passed.Strobe intensity was 64%.All aim lenses were cleaned.An autotest were completed.All tests passed.The device was verified to be operating per manufacturer specifications.Root cause: a definitive root cause for the discolored plasma could not be determined.Possible causes include but are not limited to: - the patient's underlying disease state.- hemolysis in the rbc unit that was transfused to the patient.- an unidentified manufacturing defect in the disposable set.- occlusions/clots in the circuit causing shear induced hemolysis.- a misload of the disposable set.- inaccurate data entry.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h6 and h10.Investigation : the physician did not confirm that the hemolysis was due to disease state.No hemolysis testing was performed.It is not known if the rbcs separate when the product/tubing is spun or rested.There were no clots observed in the channel or channel lines.No custom prime was performed.The disposable lot query was performed for lot 2001163330 and no similar reported occurrences were received against this lot to date.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.

Event Description

Pursuant to european personal data protection laws, patient information is not available from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10013663
• MDR Text Key: 196390704
• Report Number: 1722028-2020-00195
• 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
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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: 2001163330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00055 YR
• Patient Weight: 62