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 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the solutions attached to the machine were anticoagulant citrate dextrose solution (acd-a) and 0.9% normal saline (nacl).Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that approximately 10 minutes into a red blood cell exchange (rbcx) on a spectra optia device the operator observed discoloration in the plasma line where the plasma separates and the device alarmed that cells were detected in the plasma line from the centrifuge.Per the customer, the plasma lines were a pink, salmon color.The operator consulted the physician who stated to continue the procedure to see if there were any changes.The laboratory was also consulted and stated the plasma was not discolored from the previous complete blood count (cbc).The customer informed that the patient received 2 out of the 8 units of red blood cell exchange.No medical intervention was reported, and the patient is reported as stable.The solutions were correctly attached to the machine, no clots were observed in the channel or channel lines, no custom prime was performed, and all red blood cell (rbc) products used were within expiry.The exchange 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: 19213186
• MDR Text Key: 341713855
• Report Number: 1722028-2024-00160
• 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
• Report Date: 04/30/2024

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: 2401083241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American