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

Model Number	3610001
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to verify the reported condition.The technician tightened the screws on iv pole clamp and removed/replaced cable arm assembly.The tech verified machine functioned correctly as per cable arm assembly remove/replace instructions.Successful full auto test was performed before releasing machine to service.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 device was loose.There was not a patient or operator involved at the time of the iv pole being loose, therefore patient information is not reasonably known.
Event or Problem Description
The customer reported that the iv pole on the spectra optia device was loose.There was not a patient or operator involved at the time of the iv pole being loose, therefore patient information is not reasonably known.
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to verify the reported condition.The technician tightened the screws on iv pole clamp and removed/replaced cable arm assembly.The tech verified machine functioned correctly as per cable arm assembly remove/replace instructions.Successful full auto test was performed before releasing machine to service.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Root cause: a root cause assessment was performed for this complaint.The root cause of the loose iv pole was determined to be related to the need for an iv pole clamp screw adjustment.The root cause of the loose touch screen was determined to be related to component wear and tear.

• 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
• MDR Report Key: 15016043
• Report Number: 1722028-2022-00229
• Device Sequence Number: 6162485
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 3610001
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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