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

Catalog Number 10315

Device Problems Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported there was an adverse event with optia involving the quality of collection of hematopoietic cells.Further procedural details are not available at this time and it is unknown if medical intervention was required for this event.Patient information is 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.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, h.6 and h.10.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: - the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.- activation of platelets as a result of the donor's physiology.- when a dual-lumen catheter is used during calcium supplementation, there is some risk of recirculation.Calcium infused at the return site could be pumped into the extracorporeal circuit rather than to the donor.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.- excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.

Manufacturer Narrative

Investigation: a disposables history search confirmed there were no similar occurrences reported on this lot worldwide.The run data file was analyzed for this event.Review of the dlog did not show any conclusive signs related to lower collection efficiency or clumping during the procedure.The procedure had very few interruptions and appeared to run smoothly for the majority of the procedure.The data recorded from the rbc detector (i.E.R/g ratios) indicated the concentration of cells flowing through the collect port was in the normal range for a cmnc procedure.The collection preference (cp) is the main value used to optimize the collection.For cmnc procedures, the system defaults to a cp of 50 but it can be set anywhere between 10 and 90.This should be changed during the run to meet the unique conditions of each patient and the desired outcome for the product.Typically, if the donor has high wbc and platelet counts a lower collection preference needs to be used.If the donor has low counts, a higher collection preference should be used.The donor's blood physiology can also influence what collection preference needs to be used.Decreasing the cp further and earlier on in the procedure will increase the overall yield of target cells as, generally, a low cp means a higher concentration of cells.It is also important to note though that as target cells are being depleted, the concentration of rbcs will increase.Therefore, the cp may need to be increased as the procedure progresses to avoid depletion of rbcs and continue to collect the targeted cell population.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

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.The customer stated that the product was discarded in the lab and the administration of calcium appears to be planned as part of the donation.During the run, 4.6 volume was processed (16200 tvb); 268ml collection bag; total 1157 ml acd used (1:15 ratio) replacement of calcium chloride 10% 25ml (5 ampoules of 5ml) in ns 0.9% 250ml during entire procedure 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

Uppon follow-up with the customer, the customer clarified that this was an allogeneic donor.The donor information is provided in a.2, a.3, and a.4.Patient (donor) identifier was not provided.There was no alarm during the procedure.The donor was released without any incident and the collect bag was discharged after the clot was identified at the lab.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11065758
• MDR Text Key: 223460213
• Report Number: 1722028-2020-00570
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

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: 01/01/2022
• Device Catalogue Number: 10315
• Device Lot Number: 2001073230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/21/2021; 02/08/2021; 03/17/2021
• Supplement Dates FDA Received: 02/08/2021; 03/03/2021; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00019 YR
• Patient Weight: 50