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

Model Number 61000

Device Problems Mechanical Problem (1384); Device Slipped (1584); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.Technician disassembled and reassembled iv pole button and cleaned the iv pole as needed.Operation and auto test were performed successfully.Investigation is in process and an update will be provided.

Event Description

The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 (h.11) and corrected information in d.4 investigation: a terumo bct service technician checked out the machine at the customer site.Technician disassembled and reassembled iv pole button and cleaned the iv pole as needed.Operation and auto test were performed successfully.The device serial number history report indicates two more related issues have been reported for this device.One year of service history was reviewed for this device with two other issues related to the reported condition identified.Mdrs: 1722028-2024-00054 and 1722028-2024-00014.Correction: the service technician cleaned the button, and entire iv pole, 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 a sticking iv pole button.

Event Description

The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: a terumo bct service technician checked out the machine at the customer site.Technician disassembled and reassembled iv pole button and cleaned the iv pole as needed.Operation and auto test were performed successfully.The device serial number history report indicates two more related issues have been reported for this device.Correction: the service technician cleaned the button, and entire iv pole, and verified proper operation of the device.Investigation is in process and an update will be provided.

Event Description

The customer reported that the iv pole on the spectra optia equipment unexpectedly lowers down.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
• Type of Device: 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: 18624202
• MDR Text Key: 334335088
• Report Number: 1722028-2024-00037
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other