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

Catalog Number 4123201

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

Patient Problem Hypervolemia (2664)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: calculate final fluid balance (including saline bolus): 4329 + 574ml (machine fb) + 500 ml bolus = 5403 ml/ 4329 ml= 1.25 * 100 = 125% investigation is in process, a follow-up report will be provided.

Event Description

A customer reported to terumo bct customer support that at the beginning of a continuous mononuclear cell collection (cmnc) procedure the optia device alarmed with a notification stating that the hematocrit is too low to establish interface.After the customer assessed the patient and entered the hematocrit value against a point-of-care value to confirm, they continued the run.After roughly 45 minutes into the collection the 500ml saline bag was depleted and the customer replaced the bag with a new one and used hemostats to maintain closure of the saline line and was able to complete the collection without incident.Per follow up with the customer, the roller clamp was failing to securely close the return saline line.The saline roller clamps were on the correct lines and closed properly and no blood was seen in the saline bag.The patient was discharged from the collection center on the day of procedure per protocol and not medical intervention or symptoms were reported.The customer declined to provide the patient id.The collection set is not available for return because it was discarded by the customer.

Event Description

A customer reported to terumo bct customer support that at the beginning of a continuous mononuclear cell collection (cmnc) procedure the optia device alarmed with a notification stating that the hematocrit is too low to establish interface.After the customer assessed the patient and entered the hematocrit value against a point-of-care value to confirm, they continued the run.After roughly 45 minutes into the collection the 500ml saline bag was depleted and the customer replaced the bag with a new one and used hemostats to maintain closure of the saline line and was able to complete the collection without incident.Per follow up with the customer, the roller clamp was failing to securely close the return saline line.The saline roller clamps were on the correct lines and closed properly and no blood was seen in the saline bag.The patient was discharged from the collection center on the day of procedure per protocol and not medical intervention or symptoms were reported.The customer declined to provide the patient id.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: calculate final fluid balance (including saline bolus): 4329 + 574ml (machine fb) + 500 ml bolus = 5403 ml/ 4329 ml= 1.25 * 100 = 125% 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.Upon further review of this event it was determined that the final fluid balance was below the reportable limit.No further reporting will be provided as this does not represent a reportable event.

• 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: 17670704
• MDR Text Key: 322508274
• Report Number: 1722028-2023-00292
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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: 09/01/2023

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: 2304116141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Female