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

Catalog Number 4102204

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: received one used optia set containing blood throughout for investigation.Upon initial visual investigation, the remove line tubing was found be misrouted in the cassette organizer.No other disposable defects were identified.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that approximately 20 minutes into a procedure there were no alarms during priming and they detected no rise of plasma into the waste bag because the tubing was not clamped.Patient information is not available at this time.Per the customer, there was no medical intervention for this event.

Manufacturer Narrative

Investigation: received one used optia set containing blood throughout for investigation.Upon initial visual investigation, the remove line tubing was found be misrouted in the cassette organizer.No other disposable defects were identified.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.No reportable failures were reported.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported to terumo bct customer support that approximately 20 minutes into a procedure there were no alarms during priming and they detected no rise of plasma into the waste bag because the tubing was not clamped.Patient information is not available at this time.Per the customer, there was no medical intervention for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 18232223
• MDR Text Key: 329913498
• Report Number: 1722028-2023-00397
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4102204
• Device Lot Number: 2305083144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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