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

Catalog Number	4121201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a procedure on a spectra optia device, the operator set the plasma collection target to 500 ml and the device attempted to collect 1 l of plasma from the patient.Per the customer, after the device finished collecting 500 ml of plasma, the rbc valve opened and began to pump plasma into the nmc collection bag.It was reported that the procedure stopped, and the operator checked the target plasma on the main screen and the device showed that the plasma target was now 1000 ml.Per the customer, the device alarmed "leak detected".The customer indicated that there was no injury or medical intervention for this event.Patient information is not available at this time.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during a procedure on a spectra optia device, the operator set the plasma collection target to 500 ml and the device attempted to collect 1 l of plasma from the patient.Per the customer, after the device finished collecting 500 ml of plasma, the rbc valve opened and began to pump plasma into the nmc collection bag.It was reported that the procedure stopped, and the operator checked the target plasma on the main screen and the device showed that the plasma target was now 1000 ml.Per the customer, the device alarmed "leak detected".The customer indicated that there was no injury or medical intervention for this event.Patient information is not available at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.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.It was confirmed that the final fluid balance was 101%.No further reporting will be provided as this does not represent a reportable event.

• Brand Name: SPECTRA OPTIA
• Common Device Name: 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: 19538013
• Report Number: 1722028-2024-00246
• Device Sequence Number: 6425015
• Product Code: LKN
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Catalogue Number: 4121201
• Device Lot Number: 2310096141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown