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

Model Number 12320

Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: the procedure was complicated by poor venous access and multiple alarms.The operator observed clumping, called terumo bct clinical specialist and was advised to decrease inlet: ac ratio.Inlet: ac ratio adjusted.Clinical support advised the customer to check acd-a to ensure bag frangible was broken and appropriate ac volume dispensed - the customer confirmed.Clumping persisted and subsequent to multiple inlet flow alarms, procedure was aborted due to poor flow from inlet line.A disposable history search was performed.No additional reports of a similar issue were found.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 paraesthesia (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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had microclots in a stem cell product and lower than expected yield.During the collection procedure using a spectra optia, the patient experienced circumoral parasthesia and was administered iv calcium for citrate toxicity.Customer declined to provide patient identifier.Per the customer the patient returned for a planned second collection and the procedure was completed earlier than expected.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the aim images for this procedure did indicate the presence of clumping during the procedure.It was also confirmed that the system was in interface setup for most of the run due to configuration changes to the inlet:ac ratio and the ac infusion rate.These changes had a direct effect on the inlet flow rate and centrifuge speed which affected the packing factor and how the cells separate in the connector.These observations are likely what caused the reported low collection efficiency and the operator to end the run early.Review of the rdf and associated images for this procedure confirmed signs of clumping in the collect connector early in run.It is possible that this was related to the patient¿s blood physiology.The signals suggest that the clumping experienced during this procedure was related to inadequate anticoagulation of the extracorporeal circuit likely combined with the patient¿s individual blood physiology.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector.Additionally, it was noted that the cp, which is the main value used to optimize the collections, was increased above 50 at the start of the run then decreased to 40 for most of the remainder of the procedure.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.Patient disease state and blood physiology can also influence what collection preference needs to be used.Signals from the rbc detector (i.E.R/g ratios) indicated the concentration of cells flowing through the collect port was lower than the expected range for cmnc procedures, demonstrating the system was not collecting from the optimal location in the buffy coat.Therefore, the cp may have needed to be decreased earlier in the run and possibly further to target the desired cell population.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.Based on the rdfs associated with the 2 procedures, a definitive root cause for the platelet clumping could not be determined.Possible causes include but are not limited to: - patient¿s blood physiology - inadequate anticoagulation of the extracorporeal circuit - configuration changes to the inlet:ac ratio and the ac infusion rate.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10535941
• MDR Text Key: 207116680
• Report Number: 1722028-2020-00445
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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: 03/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2003113230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00052 YR
• Patient Weight: 51