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

Model Number	61000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the iv pole at the customer site and found that the unit's side panel was not assembled properly causing the iv pole release button to constantly engage.The technician properly assembled the side panel, verified all sensors via sts functional check, and completed and passed the auto test.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.No adverse event occurred, and no medical intervention was required.No injury was reported for this incident and no patient was connected at the time the iv pole.
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.No adverse event occurred, and no medical intervention was required.No injury was reported for this incident and no patient was connected at the time the iv pole.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a terumo bct service technician checked out the iv pole at the customer site and found that the unit's side panel was not assembled properly causing the iv pole release button to constantly engage.The technician properly assembled the side panel, verified all sensors via sts functional check, and completed and passed the auto test.One year of service history was reviewed for this device with no further issues related to the reported condition identified.The device serial number history report indicates two more related issues have been reported for this device.Correction: the service technician assembled side panel correctly.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that the iv pole clamp was installed on the device.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.No adverse event occurred, and no medical intervention was required.No injury was reported for this incident and no patient was connected at the time the iv pole.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a terumo bct service technician checked out the iv pole at the customer site and found that the unit's side panel was not assembled properly causing the iv pole release button to constantly engage.The technician properly assembled the side panel, verified all sensors via sts functional check, and completed and passed the auto test.One year of service history was reviewed for this device with no further issues related to the reported condition identified.The device serial number history report indicates two more related issues have been reported for this device.Correction: the service technician assembled side panel correctly.Investigation is in process, a follow-up report will be provided.

• 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
• MDR Report Key: 20284406
• Report Number: 1722028-2024-00413
• Device Sequence Number: 20816837
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 11/06/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/11/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2014
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown