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  

Event Description

The customer reported that during the beginning of a second attempt to perform a red blood cell exchange procedure (rbcx) on a spectra optia device, the operator observed plasma that was dark amber in color in the connector and in the cassette.The device alarmed ¿cells detected in the plasma line and in centrifuge¿.The physician cannot confirm if the hemolysis is due to disease, state, or medication.No medical intervention was reported.The customer declined to provide patient id.The customer reported there was no custom prime performed and no clots were observed in the channel or channel lines.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the solutions attached to the machine were anticoagulant citrate dextrose solution (acda) and 0.9% normal saline (nacl) were correctly attached.The first reference event mentioned in b.5 was reported on mdr 1722028-2024-00160.Investigation is in process, a follow-up report will be provided.

• 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: 19213960
• MDR Text Key: 341715142
• Report Number: 1722028-2024-00161
• 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