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

Model Number 12220

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypervolemia (2664)

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that an apheresis disposable set was set up on spectra optia device.After the first bag was infused to the patient, the nurse changed the red blood cell collection (rbc) to the second bag and noticed that the normal saline (ns) was dripping even though the roller clamped was closed.The rn opened and closed the roller clamp again but it did not stop the ns from dripping.This resulted in the patient receiving extra ns, estimated to be about 250 ml.The rn discontinued the procedure and when trying to remove the tubing set from the device, the device kept alarming that the tubing was not disconnected and it did not want to eject the set even though all lines were cut and sealed closed.The disposable set was changed out and the procedure was continued with a new disposable set.Patient information and outcome were not provided by the customer.No serious injury or medical intervention occurred for this event.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.11.Investigation: the final fluid balance could not be calculated since the customer was not able to provide the serial number or the patient¿s tbv.The customer was not able to provide the lot number.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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 that an apheresis disposable set was set up on spectra optia device.After the first bag was infused to the patient, the nurse changed the red blood cell collection (rbc) to the second bag and noticed that the normal saline (ns) was dripping even though the roller clamped was closed.The rn opened and closed the roller clamp again but it did not stop the ns from dripping.This resulted in the patient receiving extra ns, estimated to be about 250 ml.The rn discontinued the procedure and when trying to remove the tubing set from the device, the device kept alarming that the tubing was not disconnected and it did not want to eject the set even though all lines were cut and sealed closed.The disposable set was changed out and the procedure was continued with a new disposable set.Patient information and outcome were not provided by the customer.No serious injury or medical intervention occurred for this event.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• 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: 16469905
• MDR Text Key: 310547884
• Report Number: 1722028-2023-00088
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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