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); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.The iv pole clamp was 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 terumo bct service technician checked out the device the customer site and adjusted and aligned the iv pole.The technician also tightened the grub screw on the power side of the iv pole lowering mechanism.Investigation is still 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.The iv pole clamp was 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
This report is being filed to provide additional information in h.6 and h.11.Investigation: a terumo bct service technician checked out the device the customer site and adjusted and aligned the iv pole.The technician also tightened the grub screw on the power side of the iv pole lowering mechanism.The device serial number history report indicates no further related issues have been reported for this device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be loosen grub screw.
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device the customer site and adjusted and aligned the iv pole.The technician also tightened the grub screw on the power side of the iv pole lowering mechanism.The device serial number history report indicates no further related issues have been reported for this device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be loosen grub screw 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 there was a clamp installed on the optia 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.The iv pole clamp was 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: 19851432
• Report Number: 1722028-2024-00309
• Device Sequence Number: 17763081
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 11/06/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/11/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2019
• 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