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 12/18/2023

Event Type  malfunction  

Event Description

The customer reported that the iv pole on the 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.

Manufacturer Narrative

Investigation: a service engineer checked out the device at the customer service and revealed no visible damage.Testing the iv pole confirmed it would intermittently drop when the lock was engaged.Discovered two loose allen screws and tightening these screws securely resolved the issue.Retesting confirmed the pole moved freely when unlocked and remained stable when locked.Since the machine was placed back, a complete auto test was performed and passed successfully.Also confirmed that there is no iv pole clamp on this machine.The device serial number history report indicates no further related issues have been reported for this device.Correction: the service technician tightened both allen screws and verified proper operation of the device.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.10.Investigation: a service engineer checked out the device at the customer service and revealed no visible damage.Testing the iv pole confirmed it would intermittently drop when the lock was engaged.Discovered two loose allen screws and tightening these screws securely resolved the issue.Retesting confirmed the pole moved freely when unlocked and remained stable when locked.Since the machine was placed back, a complete auto test was performed and passed successfully.Also confirmed that there is no iv pole clamp on this machine.The device serial number history report indicates one more related issues have been reported for this device.See mdr 1722028-2024-00037.One year of service history was reviewed for this device with one further issue related to the reported condition identified.See mdr 1722028-2024-00037.Correction: the service technician tightened both allen screws 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 loose allen screws in iv pole.

Event Description

The customer reported that the iv pole on the 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.

• 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: 18494699
• MDR Text Key: 333151109
• Report Number: 1722028-2024-00014
• Device Sequence Number: 1
• Product Code: LKN
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 02/05/2024
• 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