MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: the device was serviced at the customer site by a terumo bct technicican.The door lock issue could not be duplicated.The latch assembly was not at a 90 degree angle.The gap in the door was adjusted by replacing the door latch.Autotest and fluid run both passed.The unit was running as expected and released to the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while running a continuous mononuclear cell (cmnc) collection procedure, they were able to open the centrifuge door of the device while it was still spinning.They were able to continue and finish the collection.The customer reported there were no injuries to the donor or operator.Operator information is not available at this time.The gender and weight in a.3 and a.4 are the donor's information and were included due to a system limitation.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: additional tasks that occurred during the service of the device: during service on 02/10/2021, the camera was adjusted 3/10 of a degree and it passed at the lower/mid range setting with the centrifuge spinning at 800 rpms.The diffuser plate and reference block were also replaced to resolve the aim issues (the customer had reported consistently low collection efficiencies).The i/o one board, safety stack, and control stack were proactively replaced.The device serial number history report indicates no further related door issues have been reported for this device; however, on (b)(6) 2021, the customer reported another low collection efficiency issue and requested replacement of the device.The device was replaced.One year of service history was reviewed for this device with two (2) issues related to the reported condition identified: on (b)(6) 2021, the customer reported the alarm 'centrifuge pressure sensor malfunctioned'.During service the door lock assembly was replaced as well.On (b)(6) 2020, the customer reported that the door is ajar most of the time as well as the alarm 'door-closed sensor was not consistent'.The door sensor was verified to be operational.Two loose door screws were tightened.The customer did not report, in either record, that the door could be opened while the machine was running.Investigation is in process.A follow up report will be provided.

Event Description

Donor age is provided in a2.The customer declined to provide donor id.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 and corrected information in e.1 and e.3.Investigation: part evalution was done with the following results: door lock assembly: no problem found.I/o one cca: problem could not be verified.Safety stack: problem could not be verified.Control stack: problem could not be verified.Diffuser plate: no evaluation performed due to damage from repair.Root cause: the specific root cause of the open centrifuge door during the procedure could not be determined.Since replacement of the door lock assembly, i/o one cca, control stack cca, and safety stack cca resolved the issue, it is possible one or all of these parts caused or contributed to the failure.Additionally, it cannot be ruled out that the operator started the procedure with the door open.Since realignment of the camera and replacement of the diffuser plate and reference block resolved the aim issue, it is likely these parts caused or contributed to the reported low collection efficiencies.Other possible causes for low collection efficiency include but are not limited to: ¿patient's blood physiology interferes with separation of cellular components and chamber triggering (i.E.Abnormal rbcs, hyperviscous plasma) ¿poor mobilization of target cells due to patient's physiology and mobilization regimen ¿not processing enough blood to optimize the collection of target cells.¿incorrect setting of collection preference ¿entry of incorrect wbc and/or platelet counts ¿poor access, which resulted in pump pauses and caused the system to repeatedly re-establish the interface ¿platelet clumping which can interfere with proper separation of cells in the connector and/or chamber and can also cause system to repeatedly re-establish the interface ¿changes to the inlet pump flow rate of more than 5% during accumulation phase ¿lighting is too bright and is not within the appropriate range.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11380787
• MDR Text Key: 242745694
• Report Number: 1722028-2021-00084
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• 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: 02/25/2021

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: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/15/2021; 04/06/2021
• Supplement Dates FDA Received: 03/19/2021; 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00040 YR
• Patient Weight: 57