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	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.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 terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The service technician found a bundle of cable in front of the laver causing it to always be pressed.Moved the cables and the iv pole held in place.The device serial number history report indicates no further related issues has been reported for this device.Correction: the service technician replaced the iv pole.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 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
This report is being filed to provide additional information in h.6 and h.11 and a correction in h.11.Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The service technician found a bundle of cable in front of the lever causing it to always be pressed.Moved the cables and the iv pole held in place.The device serial number history report indicates no further related issues has been reported for this device.Correction: the service technician verified the proper operation of the device.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a bundle of cable in front of the laver causing it to be always pressed.

• 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: 19343501
• Report Number: 1722028-2024-00173
• Device Sequence Number: 7070115
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/17/2024

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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2014
• 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