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

Model Number	61000
Medical Device Problem Codes	Device Slipped (1584); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site.The technician was able to verify the reported event and found the iv will not hold upright position.The technician replaced the iv pole, verified operation and successfully completed an auto test.The device serial number history report indicates one more related issues have been reported for this device.Correction: the service technician tightened both allen screws and verified proper operation of the device.Investigation is still in process and 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.The iv pole clamp was not installed at the time of this event.No injury was reported for this incident and no patient was connected at the time the iv pole.
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site.The technician was able to verify the reported event and found the iv will not hold upright position.The technician replaced the iv pole, verified operation and successfully completed an auto test.The device serial number history report indicates two more related issues have been reported for this device.One year of service history was reviewed for this device with two other issues related to the reported condition identified.Mdrs 1722028-2024-00014 and 1722028-2024-00037.Correction: the service technician tightened both allen screws and verified proper operation of the device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be defective iv pole.
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.No patient (donor) was connected at the time of the event, therefore, no patient information is known.The iv pole clamp was not installed at the time of this event.No injury was reported for this incident and no patient was connected at the time the iv pole.

• 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: 18716334
• Report Number: 1722028-2024-00054
• Device Sequence Number: 8531244
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: BK130065
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2014
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown