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

Model Number	61000
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the iv pole on the optia equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.The iv pole clamp was not installed no injury was reported for this incident and no patient was connected at the time the iv pole.Was sliding down, therefore no patient information is reasonably known.
Additional Manufacturer Narrative
Investigation: a service engineer checked out the device at the customer service and revealed no visible damage.Testing the iv pole confirmed it would intermittently drop when the lock was engaged.Discovered two loose allen screws and tightening these screws securely resolved the issue.Retesting confirmed the pole moved freely when unlocked and remained stable when locked.Since the machine was placed back, a complete auto test was performed and passed successfully.Also confirmed that there is no iv pole clamp on this machine.The device serial number history report indicates no further 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 in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.10.Investigation: a service engineer checked out the device at the customer service and revealed no visible damage.Testing the iv pole confirmed it would intermittently drop when the lock was engaged.Discovered two loose allen screws and tightening these screws securely resolved the issue.Retesting confirmed the pole moved freely when unlocked and remained stable when locked.Since the machine was placed back, a complete auto test was performed and passed successfully.Also confirmed that there is no iv pole clamp on this machine.The device serial number history report indicates one more related issues have been reported for this device.See mdr 1722028-2024-00037.One year of service history was reviewed for this device with one further issue related to the reported condition identified.See mdr 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 loose allen screws in iv pole.
Event or Problem Description
The customer reported that the iv pole on the optia equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.The iv pole clamp was not installed no injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.

• 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: 18494699
• Report Number: 1722028-2024-00014
• Device Sequence Number: 6985390
• Product Code: LKN
• 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): 01/11/2024

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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/05/2024
• 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