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

Model Number 10310

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the customer, the correct solutions were attached to the proper lines and no data entry errors occurred.The total amount of ac delivered (ml): acd-a used 1159 ml.62 ml on the product.Investigation is in process.A follow-up report will be provided.

Event Description

The customer contacted terumo bct customer support and reported seeing platelet clumping in the connector and the collect line during a continuous mononuclear cell (cmnc) collection procedure.Per the customer, the ac ratio was 12:1 and they were 1.5 hours into the collection procedure.Tbct customer support recommended to decrease the ac ratio to 6:1 and continue until no more platelet aggregates were seen, then increased to 8:1.The customer reported pushing a total of 15 gram of calcium gluconate per protocol.The donor indicated feeling nauseated with a potential citrate reaction and the blood pressure (bp) decreased from 113/70 to 75/33.A bolus of 1000ml saline was given for hydration.The patient was stabilized, and a new set was set up and the procedure was able to be completed.Per the customer, the patient was stable and able to go home following collection procedure.Patient identifier is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure and/or donor sensitivity to anticoagulant.A definitive root cause for the clumping 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 patient.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.- giving a bolus of calcium rather than a continuous infusion could also increase the likelihood of clumping in the circuit.- excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.

Manufacturer Narrative

This report is being filed to provide additional information in h10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9886146
• MDR Text Key: 186849753
• Report Number: 1722028-2020-00134
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

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 Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 02/08/2021; 03/15/2021
• Supplement Dates FDA Received: 02/16/2021; 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00026 YR
• Patient Weight: 62