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

Catalog Number 4122201

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that one hour into a red blood cell exchange (rbcx) procedure on a spectra optia device, the device alarmed cells were detected in the plasma line from the centrifuge.The physician ordered a panel for possible transfusion or hemolysis reaction.The patient was reported to be stable.Patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Customer submitted two different photographs.The first photograph shows a used spectra optia exchange disposable set containing blood throughout loaded on the machine.There is slight color variation in the plasma observed.Investigation is in process and a follow-up report will be provided.

Event Description

The customer reported that one hour into a red blood cell exchange (rbcx) procedure on a spectra optia device, the device alarmed cells were detected in the plasma line from the centrifuge.The physician ordered a panel for possible transfusion or hemolysis reaction.The patient was reported to be stable.Patient information is 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: 19202299
• MDR Text Key: 341713370
• Report Number: 1722028-2024-00156
• 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: 04/29/2024

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: 4122201
• Device Lot Number: 2311103141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2023
• 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