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

Catalog Number 4122201

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

Patient Problems Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer called terumo bct customer support and reported that during a red blood cell exchange (rbcx) procedure there were access issues, air in the green line, air in the redline in the centrifuge, and air in the clear line coming out of the centrifuge.The customer wanted to know if they needed to start over with another set and since they had been troubleshooting for 20 minutes already customer support recommended that they do start over with another set.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

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called terumo bct customer support and reported that during a red blood cell exchange (rbcx) procedure there were access issues, air in the green line, air in the redline in the centrifuge, and air in the clear line coming out of the centrifuge.The customer wanted to know if they needed to start over with another set and since they had been troubleshooting for 20 minutes already customer support recommended that they do start over with another set.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

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.The customer did not allege air past the point of last detection.No further reporting will be provided as this does not represent a reportable event.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the most likely root cause is due to the access issues experienced by the operator.A definitive root cause of the access issues could not be determined.Possible causes include but are not limited to: patient access was not properly positioned inlet line or single-needle connector was obstructed due to kinks or clamps clumping due to inadequate anticoagulation inlet pump flow rate was too high for the size of the patient access defective access pressure sensor (aps).

Event Description

The customer called terumo bct customer support and reported that during a red blood cell exchange (rbcx) procedure there were access issues, air in the green line, air in the redline in the centrifuge, and air in the clear line coming out of the centrifuge.The customer wanted to know if they needed to start over with another set and since they had been troubleshooting for 20 minutes already customer support recommended that they do start over with another set.Patient information and outcome are unknown at this time.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
• 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: 17799859
• MDR Text Key: 324052982
• Report Number: 1722028-2023-00315
• Device Sequence Number: 1
• Product Code: LKN
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2306053141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2023
• 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