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

Model Number 3610001

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 06/20/2022

Event Type  malfunction  

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 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 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.

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
• 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
• MDR Report Key: 15016043
• MDR Text Key: 295957765
• Report Number: 1722028-2022-00229
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 3610001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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