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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a (b)(4) service technician checked out the machine at the customer site.It was found that the iv pole would not stay up & the handle bar in the back is bent.It was determined that the device is unrepairable and the shifting of the top cap which could indicate a damaged frame.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The iv pole won't stay up & the handle bar in the back is bent.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.
Event or Problem Description
The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The iv pole won't stay up & the handle bar in the back is bent.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.10.Investigation: a terumo bct service technician checked out the machine at the customer site.It was found that the iv pole would not stay up & the handle bar in the back is bent.It was determined that the device is unrepairable and the shifting of the top cap which could indicate a damaged frame.The device serial number history report indicates no further related issues have been reported for this device.The relevant customer-facing associate was sent a letter to notify them that the device has sustained significant damage and is not repairable under original manufacturer standards.The letter informed the associate that the device should not be returned to service due to the damage sustained.The associate was asked to contact the customer and explain that this device will not be repaired.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the frame damage and iv pole failure could not be determined, one possible cause relates to damage sustained at the customer site.

• 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 ; 3032314970
• MDR Report Key: 12217469
• Report Number: 1722028-2021-00244
• Device Sequence Number: 3842084
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK120076
• 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): 07/23/2021

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: 06/29/2021
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2013
• 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