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

Catalog Number 4123201

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypervolemia (2664)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

The customer reported to terumo bct customer support that the saline line was running despite everything being clamped, at which point, they had to manually clamp it during in the run.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable lot history search indicated there was one other reported occurrence of open saline roller clamp on this lot worldwide.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: defective saline roller clamp, failure to fully close the saline roller clamp.

Event Description

The customer reported to terumo bct customer support that the during a continuous mononuclear cell (cmnc) collection procedure the saline line was running despite everything being clamped, at which point, they had to manually clamp it during in the run.The customer did not specify if the problem was related to the inlet saline or return saline roller clamp.Patient information and outcome are unknown.The collection set is not available for return because it was discarded by the customer.The customer did not respond to multiple attempts to obtain information for the investigation such as patient information, patient outcome or procedural details.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 18016329
• MDR Text Key: 326653669
• Report Number: 1722028-2023-00355
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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 Catalogue Number: 4123201
• Device Lot Number: 2306236141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• 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