MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Catalog Number 10120

Device Problem Insufficient Information (3190)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as 03/01/2024 and the set expired 08/01/2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: an unused spectra optia disposable set was received for investigation.The set was found to be assembled correctly with no kinks or missing parts.No disposable defects were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as (b)(6) 2024 and the set expired (b)(6) 2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• 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: 19061945
• MDR Text Key: 340364449
• Report Number: 1722028-2024-00132
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 10120
• Device Lot Number: 2108313130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other