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

Model Number	61000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Serial number and manufacture date are not available at this time.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Per a tweet, a customer stated: "and also remember that patient was passed away tragically at the (b)(6) 1 right?.I think that was simply too tragic because i am have witnessed it when taking intravenous fusion on terumo device that i've been also knew how to operator it though", this report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Patient information and procedural details are unknown at this time.
Event or Problem Description
Per a tweet, a customer stated: "and also remember that patient was passed away tragically at (b)(6) hospital right? i think that was simply too tragic because i have witnessed it when taking intravenous fusion on terumo device that i've been also shown how to operator it though" this report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Patient information and procedural details are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: per follow up with the customer, no further details were known.It is unclear if the reported death occurred on a terumo bct device or is related to a terumo bct disposable.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
Investigation: per follow up with the customer, no further details were known.It is unclear if the reported death occurred on a terumo bct device or is related to a terumo bct disposable.A disposable complaint history search was not carried out since the lot number could not be identified.Regional tbct business and quality management were contacted to see if further details of this event could be verified.This hospital does not use terumo bct equipment, trima accel or spectra optia devices.They use terumo devices, such as terumo infusion pump, terumo syringe pump, terumo® advanced perfusion system 1.Regional tbct support contacted the department of equipment and disposables of children¿s hospital 1.The hospital stated they have not encountered any death case related to medical equipment from the beginning of 2021 up to now.Per terumo bct medical review, there is no current evidence to suggest that the device caused or contributed to the patient's death.Root cause: a root cause assessment was performed for this complaint.Based on the lack of clinical or investigational information, the cause of the alleged patient death is currently unknown.
Event or Problem Description
Per a tweet, a customer stated: "and also remember that patient was passed away tragically at the children's hospital 1 right? i think that was simply too tragic because i am have witnessed it when taking intravenous fusion on terumo device that i've been also knowed how to operator it though" this report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Patient information and procedural details are unknown at this time.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12197452
• Report Number: 1722028-2021-00241
• Device Sequence Number: 11639959
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 61000
• Device Catalogue Number: 61000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 11/08/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/27/2021; 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown