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

Catalog Number 12220

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

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2024

Event Type  malfunction  

Event Description

The customer reported that there was a concentration of red blood cells in the plasma line detected during a therapeutic plasma exchange (tpe) procedure.Per the customer, the operator was able to confirm the interface, and while performing a red blood cell exchange a physician confirmed there was hemolysis of red cells.The operator disabled the red blood cell (rbc) detector and was able to complete the procedure.Patient information and outcome are unknown at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: lot number, manufacture, and expiry date are not available at this time.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 hemolysis was related to patient diagnosis.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported that there was a concentration of red blood cells in the plasma line detected during a therapeutic plasma exchange (tpe) procedure.Per the customer, the operator was able to confirm the interface, and while performing a red blood cell exchange a physician confirmed there was hemolysis of red cells.The operator disabled the red blood cell (rbc) detector and was able to complete the procedure.Patient information and outcome are unknown at this time.The platelet 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: 18944578
• MDR Text Key: 338360846
• Report Number: 1722028-2024-00086
• 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
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other