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

Catalog Number 10120

Device Problems Backflow (1064); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the patient was also given calcium chloride 50 meq, magnesium 8 meq, potassium 30 meq in 500 mls of normal saline (ns) 525 ml as a part of the standard protocol at the customer site.Post procedure counts indicated that the patient's wbc count was higher than the initial count.The operator reported that the reservoir fluid was at the normal level after the incident, and before when she tried to perform the rinseback.She further stated that she was not able to perform the rinseback however the knobs turned slowly and nothing happened.The inlet pressure reading also fluctuated.A terumo bct service technician checked out the machine at the customer site.A full autotest and saline run were performed with no unexpected alarms.A functionality checked was successfully performed on the machine, valves and pump occlusion.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure on spectra optia device for an autologous donor with mantle cell lymphoma, they received multiple ¿lowlevel sensor ¿ alarms.Per the customer, they paused the procedure after the alarm occurred and checked the centrifuge for kinks.None were found and the procedure was restarted.A few minutes later, the rn noticed that whole product had drained back inside the machine.The operator terminated the procedure immediately and checked for the any leakage and found none.Per the rn, it was possible that the collected product could have been returned back to the donor.On the basis of the available data from the machine it was found that 250 mls of product was collected and no rinseback was performed.Per the physician's order, neupogen 900 mcg was administered to the patient subcutaneously.Since no product was collected on 1st day, the collection needed to be done on the proposed 2nd day.Per the customer, the patient is reported in the stable condition.Full patient id: (b)(6).The mnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information root cause: signals in the run data file showed that the optia device operated as intended.Signals from the reservoir sensors confirmed that there was a discrepancy between the volume offluid calculated to be in the reservoir and the actual volume flowing into the reservoir."low-levelreservoir sensor detected excess fluid" and "volume in collection bag may be lower thanreported" alarms occur when the reservoir sensors see more fluid in the reservoir than expected.This indicates that there is an obstruction in the collect line in the centrifuge to the chamber or inthe collect line above the centrifuge that is causing fluid that is expected to be in the collect bagto flow to the reservoir.Signals in the run data file indicate that fluid began to flow out of the product bag atapproximately 130 minutes, although there are no clear indications of what caused the collectedproduct to flow out of the product bag at this time.The most likely causes of the productdraining from the product bag are an incorrectly loaded set that caused some type of occlusion inthe collect line to the chamber or to the product bag, or there may have been some other typeof occlusion in the collect line.Prior to beginning the run, ensure the set and channel are loadedcorrectly, per the spectra optia apheresis system operator¿s manual instructions for loading thetubing set.

Manufacturer Narrative

This report is being filed to provide in correctedinformation in investigation: the run data file (rdf) was analyzed for this event.Signals in the run data fileshowed that the optia device operated as intended.Signals from the reservoir sensors confirmedthat there was a discrepancy between the volume of fluid calculated to be in the reservoir andthe actual volume flowing into the reservoir."low-level reservoir sensor detected excess fluid" and"volume in collection bag may be lower than reported" alarms occur when the reservoir sensorssee more fluid in the reservoir than expected.This indicates that there is an obstruction in thecollect line in the centrifuge to the chamber or in the collect line above the centrifuge that iscausing fluid that is expected to be in the collect bag to flow to the reservoir.Signals in the run data file indicate that fluid began to flow out of the product bag atapproximately 130 minutes, although there are no clear indications of what caused the collectedproduct to flow out of the product bag at this time.The most likely causes of the productdraining from the product bag are an incorrectly loaded set that caused some type of occlusion inthe collect line to the chamber or to the product bag, or there may have been some other typeof occlusion in the collect line.A terumo bct service technician performed an additional full functional check out, auto-test,occlusion test, and physically inspected and torque-checked the valves on this device on may 17,2019.The functionality of the valves and pumps were verified and found to be working properly.A review of the device history record (dhr) for this unit showed no irregularities duringmanufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8600220
• MDR Text Key: 144738469
• Report Number: 1722028-2019-00110
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• 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: 05/10/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 10120
• Device Lot Number: 1806213130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/14/2019; 07/03/2019
• Supplement Dates FDA Received: 06/04/2019; 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00057 YR
• Patient Weight: 91